Medical Device

INVEST Pitch Perfect winner spotlight: Strados Labs and its ‘Holter for the lungs’

Strados Labs has developed a wearable device that senses lung sounds in patients with asthma, COPD, and other respiratory disorders. The startup, which has FDA clearance and a growing list of customers, was judged the winner in the Pitch Perfect competition at MedCity News’ recent INVEST Digital Health conference.

Bring your next life science meeting to life in Winnipeg, located in the centre of Canada

Manitoba’s capital city is the leading pharma manufacturing centre in Western Canada and has the ecosystem to draw on to host a successful event. Informatics research organizations and cutting-edge R&D centres make Winnipeg an innovative hub. Winnipeg offers more than 7,100 hotel rooms throughout the city, with many of the 1,900 downtown rooms connected by …

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4 Things Healthcare Facilities Should Know About Medical Device Recalls

Joan Melendez, Founder & President of Xcelrate UDI More than 4 million recalled medical devices may harm patients in 2021. And that’s just what we can see has been “posted” on the FDA site through June 25, 2021. The number of medical device recalls issued halfway through 2021 is far higher than in the previous …

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FDA Clears World’s First and Only Smart Knee Implant

What You Should Know: – Zimmer Biomet Holdings, a global medical technology leader, and Canary Medical, a medical data company, announced U.S. Food and Drug Administration (FDA) De Novo classification grant and authorization to market the tibial extension for Persona IQ®, the world’s first and only smart knee cleared by the FDA for total knee …

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MindRhythm Raises $5M for Stroke Triage Medical Device in EMS Settings

What You Should Know: – MindRhythm, a medical technology company focused on preventing neurological injury in stroke, today announced it has raised $5 Million in an oversubscribed round of seed funding. Principal investors include Pierre and David Lamond; Corey Goodman, PhD, Managing Partner of venBio and Board Chairman for MindRhythm; DCVC; Aestus Capital; Perseverance Capital …

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INVEST Precision Medicine winner spotlight: Nia Therapeutics

The FDA has yet to approve a therapy for memory loss. Nia Therapeutics is developing a medical device that stimulates the brain to bring it back to a “good memory state,” and it was judged the winner in the life sciences track of the INVEST Precision Medicine Pitch Perfect Competition.

First US patient gets total heart replacement with CARMAT device

An experimental artificial heart developed by French medical device specialist CARMAT has been implanted into the first of 10 subjects due to be enrolled in a US trial. The Aeson bioprosthetic device has already been implanted in a number of European patients with end-stage biventricular heart failure – affecting both sides of the heart – …

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How SaMD benefits pharma, patients, and clinicians, and how to get it right

Matt Norton, Vice President of Marketing & Commercial Development, S3 Connected Health Pharma companies are now developing more Software as a Medical Device (SaMD) as they present the best opportunities to expand their offering and broaden the value they can bring with digital health solutions. Yet, while pharma companies are familiar with the concept of digital …

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Talking about Cybersecurity Vulnerabilities in Medical Devices Shouldn’t be Taboo

Nastassia Tamari, Director of Information Security Operations for BD According to the National Vulnerability Database, 18,353 vulnerabilities were reported in 2020. That’s nearly three times the volume of vulnerabilities reported five years ago, and higher than any year in the previous two decades. Given the rise in connected devices, this increase is not entirely unexpected. …

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Neuroelectrics gets $17M for new take on electrical therapy for epilepsy, depression

Neuroelectrics is planning a pivotal test of its wearable medical device, which delivers brain electrical stimulation to treat epilepsy. The startup’s Series A round of funding was led by Morningside Ventures.

Validic Integrates Medical Device Data with Wellframe App

What You Should Know: – Today, Wellframe and Validic® announced a strategic collaboration today, empowering Wellframe members to integrate medical device data within the Wellframe mobile app. This integration with Validic will first enable Wellframe users to track their blood glucose levels across 50 glucometer devices, right from the Wellframe app. Wellframe’s ability to collect …

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Q1 2021 Health IT/Digital Health PC/VE, M&A, IPOs/ SPACs Activity

The first quarter of 2021 has been one of investor optimism as the vaccine rollout continues ahead of expectations and economic activity begins to accelerate in response.  Within the Health IT industry, the already strong investment and M&A trends seen in 2020 have only accelerated.  Over the course of the quarter, we observed $7 billion in private …

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Meet our new Chair Deborah Keller

Deborah Keller is a dynamic woman who gives off an immediate sense of warmth and humor. The moment she joined our video chat, she began sharing stories about her life in lockdown, admitting to feeling so cooped up that she painted her laundry room at 9 pm the night before. However, underneath her easy-going exterior …

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Meet our new Chair Deborah Keller

Deborah Keller is a dynamic woman who gives off an immediate sense of warmth and humor. The moment she joined our video chat, she began sharing stories about her life in lockdown, admitting to feeling so cooped up that she painted her laundry room at 9 pm the night before. However, underneath her easy-going exterior …

Meet our new Chair Deborah Keller Read More »

BioIntelliSense Partners with Leukemia & Lymphoma Society for Continuous Monitoring in Clinical Trials

What You Should Know: –BioIntelliSense announced it has entered into a strategic partnership with The Leukemia & Lymphoma Society (LLS) to incorporate the BioSticker™ platform in clinical trials of hematological cancer patients. – The LLS clinical trials will include use of the BioSticker medical device for the continuous collection of vital sign and physiological data …

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Life Sciences Firm OrbiMed Raises $3.5B Across Private Investment Funds

What You Should Know: Life sciences investment firm OrbiMed announced $3.5 billion in commitments for its latest private investment funds, including $1.5 billion for OrbiMed Private Investments VIII, $800 million for OrbiMed Asia Partners IV, and $1.2 billion for OrbiMed Royalty & Credit Opportunities III. The three new funds include a broad range of medical …

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ECRI Institute: Top 10 Health Technology Hazards to Watch in 2021

What You Should Know: – ECRI Institute identified the complexity of managing medical devices with COVID-19 emergency use authorization as the number one technology hazard in its Top 10 Health Technology Hazards for 2021 report. ECRI Institute’s Top 10 Health Technology Hazards, now in its 14th year, identifies top health technology concerns that warrant attention from healthcare leaders. The …

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MedLumics raises €18 million for atrial fibrillation device

MedLumics has raised another €18 million (around $22 million) to fund clinical trials of its optically-guided imaging system used to guide a surgical procedure for atrial fibrillation (AF) – a serious heart condition that causes an irregular heartbeat.  The Spanish biotech says the latest round – which comes after a $3.8 million first round in …

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Why Cancer Registries are Part of America’s Fight for Racial Equality

Warren A Whyte, Ph.D., VP Scientific Partnerships at ConcertAI According to a 2019 study in the Proceedings of the National Academy of Sciences, one in 1,000 Black males can expect to die at the hands of the police. Black males were also 2.5 times more likely to die during an encounter with police than white …

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Carlyle Group, Brighton Park Capital Invest $200M in Indian Health Tech Provider Indegene to Fuel Global Expansion

What You Should Know: – The Carlyle Group and Brighton Park Capital invests $200M in Bangalore, India-based Indegene to accelerate company’s global expansion and consolidate its industry-leading position in healthtech solutions. – Founded in 1998 by five first-generation entrepreneurs, Indegene has emerged as the leading digital transformation partner to the global life sciences industry. With …

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Challenges of Operationalizing Remote Patient Monitoring Data

Roberto Martinez, President, Mexico, Encora Among the many evolving technologies in the healthcare industry, there may be none more important or impactful than remote patient monitoring (RPM) hardware and software solutions. This technology is opening up new possibilities in extended healthcare – saving patients money, limiting visits to the doctor’s office, and providing healthcare professionals …

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Tyto Care Launches FDA-Cleared Fingertip Pulse Oximeter Medical Device

What You Should Know: – Tyto Care announces the launch of its fingertip Pulse Oximeter device, allowing users to measure their own blood oxygen saturation level and heart rate from the comfort and safety of home. – Expanding its clinic-quality remote capabilities, TytoCare users will be able to perform a remote blood oxygen exam, allowing …

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Philips Acquires Medical Device Integration Platform Capsule for $635M

What You Should Know: – Philips announces the acquisition of Capsule, a leading vendor-neutral Medical Device Integration Platform with a software-as-a-service business model – The Capsule acquisition is a strong fit with Philips’ strategy to transform the delivery of healthcare along the health continuum with integrated solutions. Philips, today announced that it has signed an …

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Cerner Leadership Changes, Other Key Executives Hires

Travis Dalton Dan Devers 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 …

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M&A: TigerConnect Acquires Hospital Middleware Solution Critical Alert

What You Should Know: – TigerConnect has announced an expansion in their suite through the acquisition of Critical Alert, a leading provider of enterprise-grade middleware for hospitals and health systems. – For the hundreds of thousands of nurses that currently use TigerConnect, these new capabilities will deliver real-time, contextual information to their mobile device or …

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UCHealth Taps Conversa Health to Track COVID-19 Vaccine Effects on Frontline Healthcare Workers

What You Should Know: – Conversa Health’s COVID-19 programs now include patient monitoring pre- and post-vaccination, education on vaccines, and appointment reminders. – Healthcare workers at UCHealth in Colorado are receiving 24/7 monitoring of vital signs two days before and seven days after receiving their vaccinations courtesy of Conversa Health. Conversa Health, a Portland, OR-based …

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More Than 45 Million Medical Images Are Openly Accessible Online

What You Should Know: – CybelAngel tools scanned approximately 4.3 billion IP addresses and detected more than 45 million unique medical images left exposed on over 2,140 unprotected servers across 67 countries including the US, UK, and Germany. – The report highlights the security risks of publicly accessible images containing highly personal information including ransomware …

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Medical Device Design: 4 Ways Designers Can Create Medical Devices That Work for Everyone

Stuart Karten, Founder/President, Karten Design Medical device design has been going through sweeping changes over the last decade.  Ten years ago, medical device companies weren’t concerned with delivering consumer-level design: Devices that are both attractive and intuitively easy to use by a wide variety of users.  Then the Affordable Care Act was passed, and adherence …

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Cerner Invests in Elligo to Make Clinical Trials Accessible for Health Systems of All Sizes

What You Should Know: – Cerner announced a strategic investment in Elligo Health Research, a leading research organization that enables clinical trials with nationwide community-based health care practices. – Cerner plans to expand the data and tools available in the Cerner Learning Health Network to offer additional clinical trial resources to community and rural hospitals …

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Israeli Digital Health Startup G Medical Innovations Withdraws $30M US IPO

What You Should Know: – Israeli-based G Medical Innovation has withdrawn its plans for an initial public offering (IPO) on Tuesday, Nasdaq first reports. – The company originally filed an IPO to raise $30 million by offering 5 million shares at a price range of $5 to $7 last month to list on the Nasdaq …

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KLAS Spotlight on Zoom for Healthcare Examines Early Outcomes

Source: Zoom KLAS recently issued a Spotlight on Zoom for healthcare. KLAS Spotlights are first looks at new and emerging technology. Everyone knows Zoom, but how well does the solution perform for healthcare organizations looking to handle the immediate demands created by COVID-19 as well as develop long-term strategic initiatives? In this Spotlight, KLAS examines …

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FundamentalVR Expands VR Surgical Capabilities to Ophthalmology

What You Should Know: – Today, FundamentalVR, global pioneers in immersive VR surgical skills training and skills data analytics, announced the expansion of its surgical specialty capabilities with the addition of ophthalmology. The new capabilities allow it to support medical device and life science companies in improving the way they bring new tools and procedures …

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Targeted Drug Delivery Devices: An Attractive Option for Improving the Efficacy of Biologics

The gradual shift of healthcare industry towards the development of biologics is a well-known fact. Owing to this shift, there are over 1,000 cell and gene therapies which are being developed for the treatment of various disorders, majority of them being oncological disorders, cardiovascular disorders and neurological disorders.  Additionally, over the last decade, multiple immunotherapies …

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Former KKR Vet Jim Momtazee Launches Healthcare Investment Firm, Patient Square Capital

Jim Momtazee, Managing Partner at Patient Square Capital What You Should Know: – Former KKR veteran Jim Momtazee announced the launch of Patient Square Capital, a partnership being purpose-built to become the preeminent investment firm in healthcare.  – Patient Square will partner with best-in-class management teams whose products, services, and technologies improve health.  – Prior …

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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 …

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Medical Device CROs – The next Growth Opportunity

Over the past decade, numerous scientific and technological breakthroughs in the medical device industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for high quality and efficient medical devices, driven by a growing geriatric population and increasing incidence of various chronic clinical conditions, is on the rise. …

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COVID-19 Has Permanently Shifted Patient Behavior Towards Virtual Care

What You Should Know: – The COVID-19 crisis has significantly impacted the patient care paradigm, and the ripple effects have altered patient behaviors and expectations, requiring a significant change in how life sciences companies engage with and support patients – Accenture surveyed 2700 patients about changes in care during COVID-19 and found a major shift …

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Philips and BioIntelliSense Integrate to Enhance Remote Patient Monitoring

What You Should Know: – Philips integrates the BioIntelliSense FDA-cleared BioSticker™ sensor as part of its remote patient monitoring solutions for patients outside the hospital. – Multi-parameter sensors aid monitoring across multiple chronic conditions with medical-grade vital signs for physicians to remotely track core symptoms, including COVID-19. – Healthcare Highways is the first to leverage …

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Increasing Prevalence of Chronic Diseases- Driving the Demand for Self-Administration Devices, Like Autoinjectors

Over the last decade, autoinjectors have emerged as a promising therapeutic commodity for safe administration of parenteral therapies. Patients who suffer from chronic diseases, such as diabetes, rheumatoid arthritis and multiple sclerosis, often require frequent dosing of medication which poses significant inconvenience to them for visiting proper healthcare centers. Hence, autoinjector devices enable such patients …

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