Cerner Leadership Changes, Other Key Executives Hires

Cerner announced some leadership changes promoting long-time associates Travis Dalton to Chief Client & Services Officer and Dan Devers to Chief Legal Counsel. After long, respected, meaningful careers at Cerner, John Peterzalek and Randy Sims will be departing.


Cognoa, the leading pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with autism and other behavioral health conditions appoints Eric B. Mosbrooker as Chief Operations Officer. Mosbrooker will be responsible for overseeing and leading the global commercialization of the company’s product offerings, expanding Cognoa’s operational capabilities and implementing scalable business processes.


Discovery Health Partners announced that Sameer K. Mishra has joined the company as Chief Information Officer. Leveraging his significant health payer technology experience, Mishra will lead Discovery’s dedicated IT staff and evolve the company’s technology platform.


Medical Microinstruments (MMI) SpA, hires Mark Toland as Chief Executive Officer. He brings more than 25 years of experience in the medical device industry and most recently served as President and CEO of Corindus, a vascular robotics company that Siemens Healthineers acquired for $1.1 billion in 2019. Following the CE mark of MMI’s Symani Surgical System® in 2019 and successfully completing the first human use cases in 2020, Toland will drive the company’s strategic direction from the developmental stage to broad commercialization.


Dr. Marilyn Ritholz and Dr. David Horwitz will join Chairman Eric Milledge on Dario Health’s scientific advisory board. Dr. Ritholz is a psychologist at Joslin Diabetes Center, a Harvard Medical School affiliate, and Dr. Horwitz is the former Global Chief Medical Officer of Johnson and Johnson Diabetes Institute. They will work on advancing Dario’s technical leadership and help to guide the development of its technology roadmap.


DrChrono expands its senior leadership team with two new hires joining the company. Shahram Famorzadeh will be joining as Senior Vice President of Engineering, responsible for scaling DrChrono’s platform to the next level to support its growing network of physicians and practices, and Jason Rasmussen has joined as Senior Vice President of Revenue, contributing his expertise to DrChrono’s financial operations team.


Vave Health announced two additions to its executive team and advisory board to support the company’s accelerated growth in the medical imaging market. David Garner, a long-time veteran of point-of-care ultrasound and previous vice president at Butterfly Network, brings more than 22 years of experience to Vave Health, and Terri Bresenham, founder of TruNorth Health Advisors and recognized global healthcare expert, joins as a member of the company’s advisory board.


Anang Chokshi, PT, DPT, OCS, SCS joins Include Health as Chief Clinical Officer (CCO). Chokshi joins IncludeHealth’s executive team to provide clinical and technical expertise as IncludeHealth expands its portfolio of products. 


Conversion Labs, Inc. appoints licensed personal care and wellness physician and psychiatrist, Dr. Anthony Puopolo, to the new position of chief medical officer. Dr. Puopolo will be responsible for overseeing the company’s rapidly expanding network of state-licensed physicians and ensuring that the company is delivering the highest quality of care.


BioCardia®, Inc. appoints Krisztina Zsebo, Ph.D., a 31-year veteran of the biotech industry, to its Board of Directors following her election at BioCardia’s 2020 Annual Meeting of Stockholders in December 2020.


Achiko AG appoints biotechnology research scientist and entrepreneur Dr. Morris S. Berrie to the position of President, and business leader in the life science industry Richard Lingard to the position of SVP Commercialization.

ApprioHealth announces the addition of Carl Swart as chief operating officer (COO). Prior to joining ApprioHealth, Swart served as the vice president for revenue cycle for Ensemble Health Partners. Additionally, he spent nearly a decade with Mercy Health as a market vice president.

Gates Foundation Awards Caption Health $4.95M Grant to Develop AI-Guided Lung Ultrasound System

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

What You Should Know:

– Bill & Melinda Gates Foundation awards Caption
Health a $4.5M grant to support the development of an AI-guided lung ultrasound
system.

– The grant from the Bill & Melinda Gates Foundation
will be leveraged to create new AI technology that allows medical professionals
without prior ultrasound experience to perform lung ultrasounds, expanding
access to quality medical care.


Caption Health, a leading medical
artificial intelligence (AI)
company, today announced that it has received
a grant from the Bill & Melinda
Gates Foundation
in the amount of $4.95 million to support the development
of innovative AI technology for lung ultrasound. The grant was awarded to
Caption Health by the foundation due to the need to further develop solutions
that enable timely and accurate diagnosis of pneumonia, the leading killer of
children under 5, in resource-limited settings with a shortage of highly
trained physicians. 

Caption Health already has the first and only FDA cleared AI
platform that enables medical professionals without prior ultrasound experience
to perform cardiac ultrasound exams (Caption
AI
). Like cardiac ultrasound, performing lung ultrasound requires a high
level of clinical skill and specific expertise, which has limited its broad
adoption. With this grant, Caption Health will be able to expand its
first-in-class AI technology to lung ultrasound, providing healthcare workers with
real-time guidance to acquire diagnostic-quality images for each lung zone and
automated interpretation to detect key lung pathologies.

Why It Matters

“Ultrasound can be challenging for clinicians without prior experience because it requires skill in both obtaining and interpreting images. Caption Health is the leader in developing artificial intelligence that combines image acquisition and interpretation to enable clinicians to perform ultrasound regardless of skill level,” said emergency medicine physician Dr. Chris Moore, Associate Professor of Emergency Medicine, Chief of the Section of Emergency Ultrasound, and Director of the Emergency Ultrasound Fellowship at Yale. “Expanding this AI to lung ultrasound and putting it in the hands of clinicians could have profound implications for the diagnosis and treatment of pneumonia, a leading cause of death in our youngest global citizens, as well as for COVID-19 and other lung conditions.”

Lung ultrasound enables the detection of a range of
pulmonary pathologies such as pneumonia and other consolidations, pulmonary
edema, pleural effusions and pneumothorax. Furthermore, it is non-invasive,
portable and does not expose recipients to harmful radiation. As the cost of
miniaturizing ultrasound hardware decreases, Caption Health’s AI technology
solves the remaining challenge currently limiting ultrasound’s widespread use:
enabling clinicians without lengthy specialized training to acquire and interpret
diagnostic-quality ultrasound images. 

As COVID-19 cases rise, lung ultrasound is playing a
critical role in the triage and monitoring of these patients. When patients
arrive in the Emergency Department with suspicion of COVID-19, lung ultrasound
can be used for early detection of pulmonary involvement, offering higher sensitivity than chest x-rays. For those who are
diagnosed with COVID-19, lung ultrasound can be used to grade the degree of
pulmonary involvement, and to monitor changes over time. Caption Health’s AI
technology will expand access to this powerful diagnostic tool by enabling
medical professionals without prior experience in lung ultrasound to perform
these exams, and could eventually lead to lung ultrasound becoming a routine
part of point-of-care assessments.

 “Pulmonary health and cardiovascular health are closely intertwined,” said cardiologist Dr. Randolph Martin, FACC, FASE, FESC, Chief Medical Officer of Caption Health. “Abnormalities or disease states in the lungs can directly cause prominent abnormalities of cardiac function, just as disease states in the heart can lead to marked abnormalities in the lungs. By taking our unique methodology for developing breakthrough AI for cardiac imaging and applying it to lungs, we will continue to broaden the impact we can have in helping with the management of patients with conditions affecting these two vital systems.”

Future Research Plans

Having demonstrated extensive clinical validation for its
cardiac ultrasound technology, including a multi-center prospective clinical
study and numerous published abstracts, Caption Health intends to seek similar
validation for its AI lung ultrasound technology to demonstrate the ability of
the technology to equip non-specialists to perform lung ultrasound exams.

Mobile Point-of-Care Ultrasound Is Now A Frontline Warrior in Pandemic

Point-of-Care Ultrasounds is Now a Frontline Warrior in Battling The Pandemic
Diku Mandavia, M.D., SVP, Chief Medical Officer at FUJIFILM Sonosite

Health authorities need to prioritize delivery and the repurposing of mobile point-of-care ultrasound machines which have proven to be reliable, affordable, and effective in saving the lives of coronavirus patients.  


Most Americans are familiar with ultrasound technology from the scans done to check on the status of the fetus during pregnancy.  

But far fewer are aware of how valuable mobile versions of these units have also become in America’s emergency rooms where they almost instantly detect and record everything from internal bleeding, abdominal pain to life-threatening infections. 

In recent days, mobile units have suddenly become a critical global technology for scanning the chests of coronavirus victims to precisely monitor the condition of their lungs.  

We now need to raise the status of these life-saving diagnostic machines, finding and rushing them to the frontlines of hospitals where coronavirus patients are triaged and cared for.

Even before the COVID-19 pandemic, there had been elevated global demand for these mobile – called “point of care” – units that can be brought to the bedside.  Some are small handheld devices that instantly connect to a smartphone.  

International relief organizations and national health authorities have issued urgent calls to manufacturers in the last few days for any surplus or underutilized ultrasound equipment capable of performing lung scans.  They are also seeking point-of-care ultrasound units that are underutilized or are in “retired” inventory at clinics and hospitals around the world, units that can be adapted for use in lung ultrasound (LU) diagnosis.  

Sales and maintenance records from manufacturers may also be used to track down operational LU machines that are already in-country and can be drafted into urgent service during the pandemic.

Because the most desired devices are mobile and move from patient to patient, very strict hygienic procedures must be carefully monitored and managed.  

As with so many technical innovations over the past half-century, taking the technology mobile was originally funded by one of the smallest but most consequential units in our U.S. military arsenal: Defense Advanced Research Projects Agency (DARPA).  

DARPA didn’t invent ultrasound, but it did help shrink the technology to mobile size so that frontline military physicians could take the technology closer to the battlefield and save the lives of wounded warriors.  These mobile units, now ubiquitous in ICUs and in emergency rooms around the world, are much cheaper and lower risk than radiography (x-ray) units which are difficult to maneuver to the bedside of the critically ill especially with diseases as transmittable as a coronavirus.  

It turns out that these popular mobile units provide particularly precise views of distressed lungs – important tools to have when doctors need to see the exact progression of the COVID-19 virus in infected patients who are quarantined and unable to be safely moved to a remote radiology suite.  COVID-19 often presents as a respiratory invader that causes acute inflammation in the lungs, primarily as a patchy, interstitial infiltrate – a condition recognized with ultrasound imaging.  

A small but important study was just published in Radiology by the Radiological Society of North America (RSNA) on March 13 which comes from other doctors also on the coronavirus frontlines in Italy.  

That report – covering the records of emergency physicians at Ospedale Guglielmo da Saliceto in Piacenza, Italy – claims a “strong correlation” between lung ultrasound and CT findings in patients with COVID-19 pneumonia, leading the investigators to “strongly recommend the use of bedside [ultrasound] for the early diagnosis of COVID-19 patients who present to the emergency department.”

Pneumonia and respiratory failure are a principal cause of death among COVID-19 patients.  What we can assess in a lung ultrasound right now in these patients is the involvement of both lungs with basically patchy findings.  Distinctive to the disease is typically ultrasonographic B lines – wide bands of hyperechoic artifacts that are often compared to the beam of a flashlight being swung back and forth.  

If there is a significant consolidation, diagnostics may also capture imagery of hepatization of the lung.  This information is critical to monitoring, addressing, and curing pneumonia.

For these patients and hospitals in crisis, mobile lung-ultrasound units are also scanning far more patients in a short period of time than more elaborate diagnostic imaging technologies, while delivering an accurate, actionable answer on the presence and degree of infection.  

Lung ultrasound is a critical application of the point-of-care mobile units in the emergency rooms battling COVID-19 around the world, but these patients very sick with COVID-19 may also need venous access under ultrasound guidance to administer fluids and medications.  Or they may be in shock and need a shock assessment, for which point-of-care ultrasound in COVID-19 resuscitation bays and ICUs are also very useful.

The COVID-19 pandemic is expected to get worse in the U.S. before it gets better.  New York, California, and the State of Washington have set up military-style hospitals  – 250-bed infirmaries that will be fully functional hospitals for COVID-19 patients – and will be placing point-of-care ultrasound there and elsewhere where it would be much more difficult to put a CT scanner.

The challenge in meeting that urgent goal is whether we can find and deploy enough functional lung ultrasound devices to COVID-19 responders in the next several weeks to save lives that are already in danger and restore COVID-19 patients alive and well to families desperate for medical rescue.  I believe we can and will.


About Diku Mandavia, M.D.

Diku Mandavia, M.D. is the Senior Vice President, Chief Medical Officer, at FUJIFILM Sonosite Inc., and FUJIFILM Medical Systems U.S.A., Inc.  He completed his residency in emergency medicine at LAC+USC Medical Center in Los Angeles where he still practices part-time. He is a Clinical Associate Professor of Emergency Medicine at the University of Southern California.


Will Nanox Disrupt The X-ray Systems Market?

Will Nanox Disrupt the X-ray Systems Market?

With its share price falling from more than $66 to less than $24, September was a tumultuous month for Nanox.

On August 25th, the medical imaging start-up closed its initial public offering, having raised $190m from the sale of 10,555,556 ordinary shares at a price of $18 each. Money poured in as investors were sold on Nanox’s cold cathode x-ray source and the subsequent reduction in costs that it would enable, as well as the vendor’s pay-per-scan pricing model that would let the company access new, untapped markets.

A week later the shares were being traded for almost double their opening amount, and by the 11th of September, they had reached a peak of $66.67. This meteoric rise soon came to an end though, as activist short-seller Andrew Left of Citron Research published a report comparing the Israeli start-up to disgraced medical testing firm Theranos and asserted that the company’s shares were worthless.

Other commentators added to Left’s criticism, causing investors to abandon the stock. Class action lawsuits followed, with legal firms hoping to defend shareholders against the imaging company’s alleged fabrication of commercial agreements and of misleading investors.

Nanox defended itself against the Citron attack, insisting that the allegations in the report are ‘completely without merit’, but the extra scrutiny and threat of legal repercussions have left the share price continuing to plummet, falling to $23.52 at month’s end.

Vendor Impact

– New business and payment models could capture demand from new customers in untapped and emerging markets

– Vendors should be reactive. A successful launch of Nanox’s X-ray system could channel more focus and resources on the portfolio of low-end X-ray systems

– Once established, recurring services are hard to displace

– However, brand loyalty and hard-earned reputations aren’t easily forgotten

Market Impact

– Potential for disruptive technology to expand access to medical imaging and provide affordable X-ray digital solutions, delivering a significant and rapid overall market expansion

– New customer bases could have less expertise and a lack of trained professionals – ease of use becomes a critical feature

– Where X-ray system price is a battleground, and a fundamental factor driving purchasing decisions, Nanox’s proposed ecosystem offers revenue-generating opportunities

The Signify View

Assessing the viability and long-term potential of any business is a dangerous game, doubly so if it depends on a closely guarded game-changing technological innovation as is the case with Nanox. Fortunes are won and lost on a daily basis by investors, speculators, and gamblers trying to get in on the ground floor of the next ground-breaking company after being convinced by slick presentations and thorough prospectuses.

There is likely merit in some of the arguments being put forward by those on either side of the Nanox debate. For example, the lack of peer-reviewed journal articles about new technology is questionable. But, the skepticism around the feasibility of Nanox’s technology seems to ignore that research into cold-cathode x-ray generation, the cornerstone of Nanox’s offering has been ongoing for numerous years, and isn’t as out of the blue as the naysayers may suggest.

Regardless of these and other specifics in the ongoing fracas between short-sellers, Nanox, investors, and lawyers, all of whom have their own agendas, the voracity with which the stocks were initially purchased shows the keen appetite investors have for a company that would bring disruption to the X-ray systems market.

When delving into Signify Research’s data on this market, it is easy to see why. Across many developed and mature regions, the market has become relatively stable. It is one of replacement and renewal rather than selling to new customers and increasing the accessibility of X-ray imaging. Developed markets do continue to drive growth for X-ray manufacturers to some extent, particularly as a result of digitalization and favored reimbursement for digital X-ray imaging.  However, by and large, the market remains broadly flat, with a CAGR of just 2.7% forecast for the period 2018-2023.

nanox image

Figure 1: While there are some growth areas, the X-ray market as a whole is very stable

New business

Nanox has strong ambitions to outperform this underwhelming outlook by utilizing its unique and more affordable technology to offer a relatively feature-rich system, dubbed the Arc, at a far lower price than existing digital X-ray systems. Competing on price is only one part of the equation, however.

After all, there are countries where, despite their economies of scale, the multi-national market leaders in medical imaging are unable to compete with domestic manufacturers, which are able to produce X-ray systems locally, with lower overheads, and no importation costs. Globally, there are also a large number of smaller imaging vendors, which have limited, yet low-cost offerings at the value end of the market, with this increased competition driving down average selling prices.

To differentiate itself further, Nanox also plans to launch with a completely new business model. Instead of traditional transactional sales, which see providers simply purchase and pay the full cost of the imaging system in one installment, use the system for the entire shelf life of the product and then replace with an equivalent model, Nanox plans to retain ownership of its machines, but charge providers to use them on a pay-per-scan basis.

There are some regions and some situations where legislation and other factors make this model unfeasible, so Nanox will also make its products available to purchase outright, as well as licensing its technology to other firms. However, the start-up’s focus is on offering medical imaging as a service.

The company says that this shift from a CapEx to a managed service approach means that instead of competing with established vendors over market share, it will be able to expand the total market, enabling access to imaging systems in settings where they have been hitherto absent, with urgent care units, outpatient clinics, and nursing homes being suggested as targets.

According to the Nanox investor’s prospectus, current contracts already secured (although the legitimacy of these deals is one of the issues raised by the short-sellers) feature a $40 per scan cost, of which Nanox receives $14 – although the exact figure varies depending on regional economics. The contracts feature a minimum service fee equivalent to seven scans a day, although the target is somewhat higher, with each machine expected to be used to produce 20 scans a day, for 23 days a month.

If Nanox’s order book is as valid as the company insists, and it already has deals for 5,150 units in place, each system will consequently be bringing in a minimum of $27,048 dollars per year for a minimum total revenue of $139m. If the systems are used 20 times a day as Nanox hopes, that means almost $400m in sticky recurring revenues annually. To put that in perspective, one of the market leaders for X-ray imaging systems in 2018 was Siemens Healthineers, which turned over almost $2.8bn across its general radiography, fluoroscopy, mammography, mobile, angiography, and CT imaging divisions.

With an order book that is, on the face of it, this healthy, there have been questions as to why Nanox went public at all, but the listing may be required for this business model to work. The Israeli vendor says that the vast majority of the investment will be sunk into producing the Nanox scanners, and the associated manufacturing capacity. This is necessary because unlike other imaging companies selling systems on a CapEx basis, Nanox will receive nothing for delivering scanners to customers. Revenue is generated later as the systems are used.

This means that the company is effectively fronting the initial cost of the systems, so needs to get as many units installed and being used as quickly as possible to recoup its initial costs. Unlike other vendors, it cannot rely on sales of a first tranche to fund the second and so on, in its new managed service model, it is better to mass produce everything at once.

Open to exposure

There is, however, nothing to stop other, established players from switching to a similar model. This should be of concern to Nanox, after all, Siemens Healthineers or GE Healthcare already have the manufacturing capacity and capital ready to offer products in a similar way.

And of course, Nanox, shouldn’t underestimate the difficulty of disrupting a long-established market. Despite ample funding and solid products, other companies are still struggling to make an impact in other markets. For example, Butterfly Network, a vendor offering an affordable handheld ultrasound solution, has a valuation of over $1 billion and has received more than $350m in funding.

In 2019, the company turned over $28m, enough to make it the market leader in the nascent handheld category, but in a global ultrasound market worth almost $7bn, at present, it is little more than a drop in the ocean.

Nanox hopes that its own new business model would be disruptive by opening up the market to a far greater range of customers than are currently served. A nursing home, for example, might not be able or willing to allocate the cost of a CT machine from a single year’s budget, but spreading that cost as the scanner is used, and particularly if that cost is passed on to patients at a time of use, on-site imaging suddenly becomes a far more feasible proposition.

What’s more, if a company was able to increase its product’s user base there is a strong possibility for upselling additional services, software, and tools. These could be things like AI modules that increase workflow efficiency, or, especially pertinent given the pricing model could allow machines to be installed in new settings that lack on-site expertise, tools that aid clinical decision making.

Beyond that, there is also ample scope for an imaging vendor to entice a customer into its ecosystem with a scanner that has no cost at the point of delivery, before getting it to commit to its own PACS and other IT systems. Being able to fully exploit these new customers relies, in the first instance, on being able to get a foot in the door. That is why an imaging service model could be so beneficial, even if the returns on the scans themselves aren’t especially lucrative.

Features first

While adopting a new business model and securing revenue from add-ons and upselling would help established vendors countenance the price differential Nanox proposes, if we are to take the start-up at its word, addressing its feature set might be another matter entirely.

As well as just providing imaging hardware, Nanox is offering a service that, at face value, is more complete. The Arc automatically uploads all imaging data to its cloud SaaS platform. This platform would initially use AI systems to ‘provide first response and decision assistive information’ before radiologists could provide final diagnoses that could then be shared with hospitals in real-time.

Fig2

Figure 2: With teleradiology read volumes increasing, it makes sense that the necessary hardware comes baked into the Arc

There is currently limited information available about the exact nature of the so-called Nanox.CLOUD and its integration with the Arc, although several assumptions can be made:

– Firstly, although built-in connectivity is being touted as a feature with clinical benefits, its inclusion is as likely to be a necessity as a design choice, given that Nanox presumably needs to be able to communicate with the systems in order to find out scan volumes and bill accordingly. Or, more drastically, render the system inoperable if people don’t keep up with payments.

– Another assumption that can be made is that the full suite of tools wouldn’t be included in the basic pay-per-scan fee. Signify’s Teleradiology World – 2020 report found that in 2020, the average revenue per read for a teleradiology platform is, in North America for example, $24.40. As such, teleradiology services would only be able to be offered at an additional cost, creating another revenue stream for Nanox.

– Another sticking point could also be Nanox’s promise to enable the integration of its cloud into existing medical systems, via APIs. While well and good in theory, the competitiveness, complexity, and proprietary nature of many medical imaging workflows, combined with the fact that many vendors have absolutely no incentive to make integration easy for the newcomer, mean that in practice, it is likely to either be a prohibitively expensive, or frustratingly limited offering. This is one area where established vendors, which already offer comprehensive medical imaging packages, have a distinct advantage.

Back down to Earth

The short positions promoted by commentators including Citron Research and Muddy Waters Research postulate that the Nanox.ARC scanner isn’t real. There are some legitimate questions, but running through their papers is also an attitude that Nanox’s claims are simply implausible, whether that is because it has an R&D budget a fraction of the size of GE, or because anonymous radiologists unrelated to the company haven’t seen anything like it before.

It is worth remembering, though, that these short sellers will benefit financially if Nanox slumps. Nanox conversely, is obviously financially incentivized to promote its technology and its potential, and it wouldn’t be the first company, to promote the limited fruits of its start-up labor in a flattering light.

As so often happens in these he said, she said situations, the truth could well lie somewhere between the two extremes. Even in this instance, even if Nanox fails to deliver on some of its more impressive promises, the fact is, it has suggested bringing a whole new customer base into play and laid out a strategy for selling to them.

With that being the case, for a big vendor the issue of whether Nanox is legitimate almost becomes moot, their focus should be what these other customers require, how to get these customers into their product ecosystems, and what add-on products, and additional services they can feasibly sell them at a later date.

If nothing else, the entire Nanox furor shows that to achieve growth in mature markets, a vendor’s innovation needs to extend beyond its products.


About Alan Stoddart

Alan Stoddart is the Editor at Signify Research, a UK-based market research firm focusing on health IT, digital health, and medical imaging. Alan joined Signify Research in 2020, using his editorial expertise to lead on the company’s insight and analysis services. 

Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

What You Should Know:

– Northwestern Memorial Hospital is the first in the
nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including
measurement of ejection fraction – the most widely used measurement to assess
cardiac function.

– Caption Health’s AI-guided cardiac ultrasound enables clinicians – including those without experience – to accurately perform diagnostic-quality exams — accelerating the availability of information and saving lives.

– Caption AI has been shown to produce assessments
similar to those of experienced sonographers in work presented to the American
Society of Anesthesiologists.


Northwestern Memorial
Hospital
is the first hospital in the United States to purchase Caption Health’s
artificial
intelligence (AI)
technology for ultrasound, Caption AI. The FDA cleared, AI-guided
ultrasound system enables healthcare providers to acquire and interpret quality
ultrasound images of the human heart, increasing access to timely and accurate
cardiac assessments at the point of care.

Performing an ultrasound exam is a complex skill that takes years to master. Caption AI enables clinicians—including those without prior ultrasound experience—to quickly and accurately perform diagnostic-quality ultrasound exams by providing expert turn-by-turn guidance, automated quality assessment, and intelligent interpretation capabilities. The systems are currently in the hospital’s emergency department, medical intensive care unit, cardio-oncology clinic, and in use by the hospital medicine group.

Democratize the Echocardiogram

Point-of-care ultrasound (POCUS) has a number of benefits. Increased usage of POCUS contributes to more timely and accurate diagnoses, more accurate monitoring, and has been shown to lead to changes in patient management in 47% of cases for critically ill patients. POCUS also allows patients to avoid additional visits to receive imaging, as well as providing real-time results that can be recorded into a patient’s electronic medical record.

“Through our partnership with Caption Health, we are looking to democratize the echocardiogram, a stalwart tool in the diagnosis and treatment of heart disease,” said Patrick McCarthy, MD, chief of cardiac surgery and executive director of the Northwestern Medicine Bluhm Cardiovascular Institute, a group involved in the early development of the technology. “Our ultimate goal is to improve cardiovascular health wherever we need to, and Caption AI is increasing access throughout the hospital to quality diagnostic images.” 

How Caption Health Works

Caption AI emulates the expertise of a sonographer by providing real-time guidance on how to position and manipulate the transducer, or ultrasound wand, on a patient’s body. The software shows clinicians in real-time how close they are to acquiring a quality ultrasound image, and automatically records the image when it reaches the diagnostic-quality threshold. Caption AI also automatically calculates ejection fraction, or the percentage of blood leaving the heart when it contracts, which is the most widely used measurement to assess cardiac function.

Northwestern Medicine has been a tremendous partner in helping us develop and validate Caption AI. We are thrilled that they are bringing Caption AI into key clinical settings as our first customer,” said Charles Cadieu, chief executive officer and co-founder of Caption Health. “The clinical, economic and operational advantages of using AI-guided ultrasound are clear. Most important, this solution increases access to a safe and effective diagnostic tool that can be life-saving for patients.”

Are Handheld Ultrasound Imaging Devices a True Revolution in Diagnostic Imaging Domain?

Advancements in the field of disease diagnostics have led to development of point-of-care medical imaging devices; handheld ultrasound scanners have emerged as a novel solution to cater to unmet need in this domain. These handheld ultrasound imaging devices are the lightest portable ultrasound devices, which permit patient diagnosis from a single transducer and transmit images to either smartphones or tablets for visualization purpose.

Ultrasound Imaging Devices

Where is Innovation and What are Key Focus Areas?

In order to highlight the innovation and recent trends, I skimmed through over 100 recent news articles related to handheld ultrasound devices and plotted a would cloud from news titles. Upon closure inspection, you would see keywords such as smart, telemedicine, cost-saving, demand, FDA, approves and several others; however, one specific keyword, COVID-19, took my specific attention. There is no doubt in saying that current crisis has created a heavy demand for the diagnosis of pulmonary symptoms, and these handy devices are also being extensively used for the diagnosis of COVID-19 and related lung infections.

Ultrasound Imaging Devices a True Revolution in Diagnostic

A Deeper Dive into Current Developer Landscape

Given the huge diagnostic potential and lucrative market opportunities offered by these devices, we at Roots Analysis conducted a detailed analysis of the current market landscape of over 100 handheld ultrasound imaging devices, based on over 10 product specific parameters. Below, I have provided a glimpse of the dataset that we have prepared for this analysis:

A Deeper Dive into Current Developer Landscape

In fact, over 80% of companies developing these devices are either small-sized or mid-sized players. This can be attributed to the fact that the unmet need within the field of diagnostic imaging has spurred the establishment of many start-ups in recent years. Further, this field has witnessed contributions from several large firms, such as (in alphabetical order) Analogic, Fujifilm, GE Healthcare, Meditech Equipment, PHILIPS and Siemens Healthineers.

Can Diagnostic Imaging Industry Truly Save Billion Dollars by Adopting these Devices?

The best thing I liked about these point-of-care diagnostic imaging devices is- high image scanning efficiency per radiologist. In fact, in one of my conversation with prominent industry stakeholders, he believes that adoption of such devices could lead to about 10% enhancement in physicians’ / radiologists’ efficiency, thereby allowing them to perform more number of scans in a single day. Further, to provide an in-depth logical understanding to our clients, we have generated a detailed insights on adoption trends and likely cost-saving potential of these devices in over 45 countries.

Can Diagnostic Imaging Industry Truly Save Billion Dollars by Adopting these Devices?

How big is Overall Market for Handheld Ultrasound Imaging Devices?

To estimate the overall market opportunities, Roots Analysis has done detailed demand and market attractiveness analysis, providing answers to key questions as: how much devices are being used annually across the globe, which therapeutic area holds highest demand, which type of end-users are likely to contribute to high revenues, and most importantly, what is the short-term, mid-term and long-term impact of COVID-19 on overall market? To find answers to these key questions and to know further about the market forecast analysis, highlighting the likely growth of the global handheld ultrasound imaging devices market, for the time period 2020-2030, check out the report here.

Check out our new Reports Here-

Global Handheld Ultrasound Imaging Devices Market, 2020-2030

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Butterfly Network Launches Mobile, Whole-Body Ultrasound with Integrated Telehealth Platform

What You Should Know:

–  Butterfly
Network launched its next-gen ultrasound product, the new Butterfly iQ+
featuring the world’s only Ultrasound-on Chip™ technology and announced a
landmark collaboration with the American College of Cardiology (ACC).


Butterfly Network,
Inc.
, today announced the launch of its next-gen ultrasound product, the
new Butterfly iQ+, the world’s only single-probe, whole-body
ultrasound system that connects to a mobile device and features an integrated
telemedicine platform. Butterfly iQ+ offers new capabilities, such as
faster frame rates, Needle VizTMtechnology, a longer battery life and
industry-leading durability. 

Ultrasound reinvented again

Butterfly iQ+ features an optimized manufacturing
process in partnership with TSMC, the largest and most advanced dedicated IC
foundry in the world. TSMC’s MEMS (microelectromechanical systems)
manufacturing technology enables the ultrasound transducer to seamlessly integrate
with CMOS (complementary metal-oxide semiconductor) technology. In addition,
TSMC possesses manufacturing capacity that can scale to realize Butterfly’s
vision of making an ultrasound device as ubiquitous as the stethoscope for the
world’s 40 million healthcare providers.

Butterfly’s innovative product has been shown to be a
particularly useful tool during the global COVID-19 pandemic due to its lung imaging
capabilities, portability and ease of cleaning, as infection control has become
increasingly important. Butterfly iQ+ brings a suite of new
capabilities that make it even easier to make fast decisions at the bedside. 

Faster, sharp imaging

With patented on-chip digital micro-beamforming enabling 15%
faster frame rates and 60% faster pulse repetition frequency, healthcare
providers can see image details in the heart, lungs and bladder with optimized
clarity. High-performance shallow imaging capabilities help support fast,
confident interventional decision-making, while deep imaging capabilities in
the lung and deep cardiac presets allow for sharp details. The Butterfly iQ+ can
help healthcare providers save time in their diagnosis and treatment of
patients, improving overall patient outcomes.

State-of-the-art technology for new levels of control

The cutting-edge Needle VizTM technology available
on Butterfly iQ+ can provide healthcare professionals with an
enhanced ability to see a needle—improving confidence for central line
placements, regional nerve blocks and other guided procedures. Additionally, in
just four seconds, clinicians can calculate bladder volume automatically using
the AI-based Auto Bladder Volume tool, allowing faster decisions at the
bedside. 

More power and durability 

The Butterfly iQ+ extends battery life by 20%
and scanning time by 100% to help healthcare providers get through their shift.
With its durable, anodized aluminum body and replaceable compression- and
stomp-tested cable, the Butterfly iQ+ offers military-grade
durability to withstand tough shifts, and has been tested to withstand an
industry-leading 4-foot drop. This next-generation device has gone through
rigorous testing to ensure shock resistance and protection from dust and water
damage. 

Pricing & Availability

Putting ultrasound on a chip, Butterfly was able
to define a new precedent of affordability by providing a whole-body ultrasound
device at $1,999, plus membership. Today, as it reinvents ultrasound
again, Butterfly iQ+ will be available for the same affordable
price. 

“Two years ago, Butterfly introduced the world’s first handheld, single-probe, whole-body ultrasound system. Since then, the device has been used by tens of thousands of medical professionals across the globe with significant clinical, economic and societal impact,” said Laurent Faracci, Butterfly Network’s Chief Executive Officer. “We have collaborated with the Butterfly community of users to define our innovation path. The first result in that journey is the new Butterfly iQ+, a big step forward for point-of-care ultrasound, with our most advanced chip ever and a number of amazing innovations and improvements that our talented team and partners developed.”

New Attacks, Regulations, and Stakes Call for New Security Strategies

New Attacks, Regulations, and Stakes Call for New Security Strategies
 Tim Callan, Senior Fellow, Sectigo

The amount of data generated by the healthcare industry is staggering—and constantly increasing.  Healthcare data encompasses the personal information of patients, doctors, nurses, and administrators. It includes diagnostic information, test results, ultrasound images, x-ray images, and of course insurance and financial information. With so much sensitive patient information there for the taking, it comes as little surprise that the healthcare industry—perhaps more than any other sector—has become a primary target for cyberattacks. Now, more than ever, it is critical that healthcare organizations take decisive action to protect their data. 

There has been no shortage of major (and notably costly) data breaches in recent years. The Equifax breach, for example, affected nearly half of all Americans. Last year’s Facebook breach was also headline news, thanks in large part to the number of users affected. Then there was a lesser-known yet costly LifeLabs breach—the largest in Canadian history—affecting more than 15 million people and prompting a lawsuit seeking north of $1 billion in damages for failure to adequately protect data. 

Healthcare data heists yield a premium, making them particularly attractive to hackers. The Center for Internet Security (CIS) notes that the “average cost of a data breach incurred by a non-healthcare related agency, per stolen record, is $158,” compared with $355 for healthcare records.

Though large, the LifeLabs incident isn’t even close to the largest healthcare data breach in history. That dubious honor goes to Anthem, which suffered a breach in 2015 that resulted in nearly 80 million compromised records. Although Anthem was able to reach a settlement with the victims for the relatively paltry sum of $115 million, both the standards for data protection and the expected remediation for failure have changed considerably in the five years since the attack. 

Regulations Raise the Stakes for Security

As the regulatory environment surrounding data breaches of all types grows more strict, hospitals and insurers have found themselves in the crosshairs of an increasingly brazen and sophisticated set of attackers. Part of the reason for this targeting stems from the relative value of healthcare records. There is a reason why “HIPAA” is an acronym known to most Americans, while other data protection laws are not.

Personal Health Information (PHI) tends to be more valuable than standard Personally Identifiable Information (PII) in large part due to its static nature. Patients can change a compromised credit card number or social security number, but not their medical history—and scammers prepared to exploit that history may render victims more vulnerable to certain types of fraud. 

New regulations are further raising the stakes for compliance. Although the California Consumer Privacy Act (CCPA) is not specifically targeted at healthcare organizations, the sector represents potentially one of the most vulnerable industries under the new law. If an organization is found to be in violation of CCPA, they have 30 days to rectify the situation or be subject to a fine of up to $7,500 per record exposed.

To put this in context: if CCPA were adopted nationwide, the LifeLabs breach that affected 15 million individuals would potentially be subject to a fine of $112.5 billion. That $1 billion lawsuits that LifeLabs is facing might sound like a lot, but under CCPA, it might mean getting off easy. This should underscore the necessity of protecting data of any kind today—let alone healthcare records. 

Ecosystems Span Email to Equipment

With the healthcare industry becoming an increasingly popular target and the penalties for breaches growing steeper, it’s important to consider that every endpoint, from desktops to devices, present attack paths for hackers. Measures as simple as stronger email security can make a big difference: in 2018 alone, Business Email Compromise (BEC) attacks resulted in more than $1.2 billion in victim losses. Spear phishing attacks, which are carried out using social engineering techniques to convince the target to relay confidential personal or financial information to what they believe is a legitimate recipient, represent an increasingly common method for attackers to gain access to user credentials or even directly obtain PII or PHI. Securing email with S/MIME (Secure/Multipurpose Internet Mail Extensions), which authenticates the sender of an email, enables employees not only to digitally sign and encrypt email communications but also to detect whether an email received has been authenticated or should not be trusted or opened.

Digital certificates are an essential part of protecting medical devices. Because they can be incorporated during the manufacturing process, these certificates allow device identity and integrity to be established from the moment they are first powered on. They also eliminate the potential for device spoofing, which protects against the possibility of counterfeit devices connecting to the network. These certificates serve as an effective proof point for savvy healthcare organizations. When vetting device suppliers and manufacturers, asking about their approach to device identity is essential. By learning to trust only manufacturers with a responsible approach to authentication, healthcare organizations can help protect one of the areas most susceptible to costly breaches. 

Medical equipment itself has also become more vulnerable. Today’s diagnostic devices are rarely standalone—most are connected to the internet, and anything connected to the internet can potentially be compromised. In fact, this compromise could occur before devices even leave the factory, potentially undermining even the most secure networks and leading medical device manufacturers to consider security starting at the assembly line; the point where device identity measures and digital certificate authentication become critical. Technologies such as secure boot can protect the integrity of a device or piece of software from the first time it is powered on. Similarly, embedded firewall and secure remote update technologies help ensure that software updates are authenticated before installation and that any communication with unauthorized devices stops before harm can be done. 

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Moving Forward with New Security Strategies

Today, health insurers, hospitals, and other patient care organizations must manage a truly massive amount of data. It is simply a fact of life. That data comes in many forms, and it can be valuable to cyber attackers for a multitude of reasons. At its core, this data is the healthcare industry’s most valuable asset—one that it must protect at all costs. 

Vulnerabilities can take many forms, from a human error to compromised devices. And while no solution can shield every possible form of attack, data and IT security administrators (and even OEMs) can take concrete steps to protect their organizations, patients, or chipsets against common attack vectors and better comply with today’s strict data protection regulations. Yes, the cloud has introduced new vulnerabilities, but it also has helped enable new security strategies and solutions that ensure every application, cell phone, server, or other connected “thing” has an authenticated digital identity.  The stakes are simply too high, and hackers have become too savvy, to rely on yesterday’s security status quo.

About Tim Callan, Senior Fellow at Sectigo

Senior Fellow Tim Callan contributes to the company’s standards and practices effort, industry relations, product roadmap, and go-to-market strategy. Tim has more than twenty years’ experience as a strategic marketing and product leader for successful B2B software and SaaS companies, with fifteen years’ experience in the SSL and PKI technology spaces.

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

What You Should Know:

– Caption Health AI is awarded FDA 510(k) clearance for
its innovative point-of-care ejection fraction evaluation.

– Latest AI ultrasound tool makes it even easier to
automatically assess ejection fraction, a key indicator of cardiac function, at
the bedside–including on the front lines of the COVID-19 pandemic.


Caption Health, a Brisbane,
CA-based leader in medical AI technology, today announced it has received FDA
510(k) clearance for an updated version of Caption Interpretation™, which
enables clinicians to obtain quick, easy and accurate measurements of cardiac
ejection fraction (EF) at the point of care.

Impact of Left Ventricular Ejection Fraction

Left ventricular ejection fraction is one of the most widely
used cardiac measurements and is a key measurement in the assessment of cardiac
function across a spectrum of cardiovascular conditions. Cardiovascular
diseases kill nearly 700,000 Americans annually, according to the Centers for
Disease Control and Prevention; furthermore, considering EF as a new vital sign
may shed light on determining cardiac involvement in the progression of COVID-19. A
recent global survey published in European Heart Journal – Cardiovascular Imaging reported
that cardiac abnormalities were observed in half of all COVID-19 patients
undergoing ultrasound of the heart, and clinical management was changed in
one-third of patients based on imaging.

How Caption Interpretation Works

Caption Interpretation applies end-to-end deep learning to
automatically select the best clips from ultrasound exams, perform quality
assurance and produce an accurate EF measurement. The technology incorporates
three ultrasound views into its fully automated ejection fraction calculation:
apical 4-chamber (AP4), apical 2-chamber (AP2) and the readily-obtained
parasternal long-axis (PLAX) view—an industry first. While ejection fraction is
commonly measured using the more challenging apical views, the PLAX view is often
easier to acquire at the point of care in situations where patients may not be
able to turn on their sides, such as intensive care units, anesthesia
preoperative settings and emergency rooms. This software provides unprecedented
access for healthcare providers to bring specialized ultrasound techniques to
the bedside.

“Developing artificial intelligence that mimics an expert physician’s eye with comparable accuracy to automatically calculate EF—including from the PLAX view, which has never been done before—is a major breakthrough,” said Roberto M. Lang, MD, FASE, FACC, FESC, FAHA, FRCP, Professor of  Medicine and Radiology and Director of Noninvasive Cardiac Imaging Laboratories at the University of Chicago Medicine and past president of the American Society of Echocardiography. “Whether you are assessing cardiac function rapidly, or looking to monitor changes in EF in patients with heart failure, Caption Interpretation produces a very reliable assessment.”

Caption Interpretation Benefits

At the point of care, a less precise visual assessment of EF
is frequently performed in lieu of a quantitative measurement due to resource
and time constraints. Using Caption Interpretation in these settings provides
the best of both worlds: it is as easy as performing a visual assessment, but
with comparable performance to an expert quantitative measurement.

Caption Interpretation was trained on millions of image
frames to correctly estimate ejection fraction, emulating the way an expert
cardiologist learns by evaluating EF as part of their clinical practice. While
virtually all commercially available EF measurement software works by tracing
endocardial borders, Caption Interpretation analyzes every pixel and frame in a
given clip to produce highly accurate EF measurements.

Caption Health broke new ground in 2018 when it received the
first FDA clearance for a fully automated EF assessment software. Two years
later, Caption Interpretation remains the only fully automated EF tool
available to providers, and, with today’s clearance, continues to be the pacesetter
in ultrasound interpretation.

“We are pleased to have received FDA clearance for our latest AI imaging advancement—our third so far this year,” said Randolph P.  Martin, MD, FACC, FASE, FESC, Chief Medical Officer of Caption Health, Emeritus Professor of Cardiology at Emory University School of Medicine, and past president of the American Society of Echocardiography. “An accurate EF measurement is an indispensable tool in a cardiac functional assessment, and this update to Caption Interpretation makes it easier for time-constrained clinicians to incorporate it into their practice.”

Recent Traction/Milestones

Caption Interpretation works in tandem with Caption
Guidance, cleared by the FDA earlier this year, as part of the Caption AI platform. Caption Guidance
emulates the expertise of a sonographer by providing over 90 types of real-time
instructions and feedback. These visual prompts direct users to make specific
transducer movements to optimize and capture a diagnostic-quality image. In
contrast, use of other ultrasound systems requires years of expertise to
recognize anatomical structures and make fine movements, limiting access to
clinicians with specialized training.

The company recently closed
its Series B funding round with $53 million to further develop and
commercialize this revolutionary ultrasound technology that expands patient
access to high-quality and essential care.