iRhythm digital heart monitoring service backed by NICE

A heart monitor developed by iRhythm has become the first product to be endorsed by NICE in a pilot project covering digital health technologies.

In new guidance, the health technology assessment (HTA) agency has recommended iRhythm’s Zio XT service for detecting abnormal heart rhythms – provided NHS organisations that deploy it collect evidence of its benefits.

The wearable electrocardiogram (ECG) patch and associated software has been tested for its ability to detect atrial fibrillation (AF) in high-risk patients, with investigators reporting higher rates of diagnosis and more use of potentially life-saving anticoagulant therapy among users, but also increased demand on healthcare resources.

Zio XT has been recommended by NICE as an option for people with suspected cardiac arrhythmias who would benefit from ECG monitoring for longer than 24 hours, as a lighter, discreet alternative to Holter monitoring, which requires patients to wear several electrodes as well as a bulky monitor.

iRhythm’s device is waterproof, so can even be taken into the shower – an important consideration as it is used for up to two weeks, day and night.

NHS patients will have access to Zio XT for three years while more data is collected to address “evidence gaps about its benefit”, according to NICE. After that period, NICE will look at the new evidence before making a final recommendation.

Assuming NHS trusts take up the tech, it could be available for more than 150,000 people in the UK, according to the HTA. As it stands, there are more than 1.2 million people with diagnosed AF in the country, and another 500,000 are thought to be undiagnosed.

People with AF are more likely to suffer a stroke, and the risk is much higher in people who are unaware they have the heart rhythm disorder.

Monitoring patients for up to 14 days means that more data from each patient will be available to review, potentially improving its ability to spot arrhythmias.

At the end of the monitoring period, users remove the patch and send it via freepost for analysis using artificial intelligence algorithms, with the findings forwarded to their clinician.

Currently 12 hospital trusts across England are evaluating the Zio XT service, which costs £265 per patient, according to NICE, which says it is likely that Zio XT will be cost saving – or at least similar in cost – to Holter monitoring.

“Throughout the COVID-19 pandemic we have seen a number of cardiac patients avoiding hospitals and suffering in silence, even when experiencing serious conditions such as strokes,” said iRhythm’s EMEA vice president Justin Hall.

“This has led to a backlog of patients requiring care, putting additional pressure on medical staff and services,” he added. “Services like Zio can help ease this backlog, offering clinically-validated services remotely.”

Earlier this year, iRhythm won a UK government AI in Health and Care Award for Zio XT, securing funding to trial the service in selected sites across the country over the next three years.

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AliveCor Receives FDA Clearance of Next-Gen EKG Algorithms

AliveCor Receives FDA Clearance of Next-Gen EKG Algorithms

What You Should Know:

– AliveCor announced they received FDA clearance of new
algorithms for use with their personal EKG devices, KardiaMobile and
KardiaMobile 6L. These additional determinations will be available via a
software upgrade for the Kardia devices in 2021.

– The additional FDA-cleared algorithms double the number
of heart rhythm disturbances that AliveCor’s Kardia devices can detect,
broadening the number of patients who are able to use their remote monitoring
devices.


AliveCor, an AI-based
personal ECG technology and provider of enterprise cardiology solutions, today
announced that the US FDA had given clearance to the company’s next generation
of interpretive ECG algorithms. AliveCor’s KardiaMobile and KardiaMobile 6L
devices, along with the Kardia app, allow users to take a 30-second ECG and
receive instant determinations of multiple cardiac conditions.

Why It Matters

This new FDA clearance positions AliveCor to deliver
AI-based remote cardiological services for the vast majority of cases when
cardiac patients are not in front of their doctor. AliveCor’s goal is to help
cardiologists efficiently provide the best possible 24/7 service to their
patients.

New Generation of AI-Powered Remote Cardiology

This new FDA 510(K) clearance provides detail and fidelity
unlike any previously seen in personal ECG devices including:

– A “Sinus Rhythm with Premature Ventricular
Contractions (PVCs)” determination if two or more ventricular ectopic
beats are detected. PVCs are a common occurrence where extra heartbeats
originate in the bottom chamber of the heart and occur sooner than the next
expected regular heartbeat. After the PVC beat, a pause usually occurs, which
causes the next normal heartbeat to be more forceful. When one feels the heart
“skip a beat,” it is this more forceful beat that is felt.

– A “Sinus Rhythm with Supraventricular Ectopy
(SVE)” determination if narrow-complex ectopy, such as premature atrial
contractions (PACs), are detected. PACs are similar to PVCs, but these beats
originate in the top chamber of the heart, however not in the heart’s natural
pacemaker, the Sinus Node.

– A “Sinus Rhythm with Wide QRS,” determination
for QRS intervals of 120ms or longer. 
Wide QRS indicates that the activation of the bottom chamber of the
heart is taking longer than expected. This could indicate a bundle branch block
in which there is a delay in the passage of heart’s electrical signals along
the bottom of the heart.

– A reduced number of “Unclassified” readings,
thereby giving users more reliable insight into their heart rhythms.

– Improved sensitivity and specificity on the company’s
“Normal” and “Atrial Fibrillation” algorithms, giving users
fewer false positives, fewer false negatives, and even greater confidence in
Kardia determinations.

– New visualizations, including average beat, PVC
identification, and a tachogram.

Kardia AI V2 is the most sophisticated AI ever brought to personal ECG,” said AliveCor CEO Priya Abani. “This suite of algorithms and visualizations will provide the platform for delivery of new consumer and professional service offerings beyond AFib, by allowing a much wider range of cardiac conditions to be determined on a personal ECG device.”

Availability

Today, KardiaMobile and KardiaMobile 6L are the most
clinically validated personal ECG devices in the world, and provide instant
detection of Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, and
Tachycardia. The new determinations and services will be available in 2021.

Eko Lands $65M to Expand AI-Powered Telehealth Platform for Virtual Pulmonary and Cardiac Exam

Eko Lands $65M to Expand AI-Powered Telehealth Platform for Virtual Pulmonary and Cardiac Exam

What You Should Know:

– Cardiopulmonary digital health company Eko raises $65M
in Series C funding to close the gap between virtual and in-person heart and
lung care.

– The latest round of funding will enable Eko to expand
in-clinic use of its platform of telehealth and AI algorithms for disease
screening and to launch a monitoring program for cardiopulmonary patients at
home.

Eko, a
cardiopulmonary digital
health
company,
today announced $65 million in Series C funding led by Highland Capital
Partners and Questa Capital, with participation from Artis Ventures, DigiTx
Partners, NTTVC, 3M Ventures, and other new and existing investors. The new
funding will be used to expand in-clinic use of the company’s platform of telehealth
and AI
algorithms for disease screening, and to launch a monitoring program for
cardiopulmonary patients at home.

Eko was founded in 2013 to improve heart and lung care for
patients through advanced sensors, digital technology, and novel AI algorithms.
The company reinvented the stethoscope and introduced the first combined
handheld digital stethoscope and electrocardiogram (ECG). Eko’s FDA-cleared AI
analysis algorithms help detect heart rhythm abnormalities and structural heart
disease. Eko seeks to make AI analysis the standard for every physical exam. The
company recently launched Eko AI and Eko Telehealth to combat the needs of the COVID-19
pandemic.

Eko Telehealth delivers:

– AI-powered and FDA-cleared identification of heart murmurs
and atrial fibrillation (AFib), assisting providers in the detection and
monitoring of heart disease during virtual visits

– Lung and heart sound live-streaming for a thorough virtual
examination

– Single-lead ECG live-streaming, enabling providers to
assess for rhythm abnormalities

– Embedded HIPAA-compliant video conferencing, or can work
alongside the video conferencing platform a health system has in place

Symptoms of valvular heart disease and AFib often go
undiagnosed during routine physical exams. With the development of Eko’s AI
screening algorithms, clinicians are able to harness state-of-the-art machine
learning to detect heart disease at the earliest point of care regardless if
the patient visit is in-person or remote.

“We are thrilled that our new investors have joined our journey and our existing investors have reaffirmed their support for Eko,” said Connor Landgraf, CEO and co-founder at Eko. “The explosion in demand for virtual cardiac and pulmonary care has driven Eko’s rapid expansion at thousands of hospitals and healthcare facilities, and we are excited for how this funding will accelerate the growth of our cardiopulmonary platform.”

AI Leads Way to Less False Positives on Remote Cardiac Monitoring Devices, Improved Results

What You Should Know:

– Cardiac patients and their cardiologists are
experiencing a high number of false positives with remote patient monitoring
devices as a result of signal artifact providing inaccurate data, which can
lead to many complications—other than medical, such as unnecessary tests and
increased medical costs.

– Ambulatory cardiac monitoring provider InfoBionic has devised a way to decrease false positives and increase efficiency.


Remote cardiac monitoring’s false positives—especially on atrial fibrillation (Afib)—hurt everyone, from the patient to the boss who will have to go without an employee when he or she has to go in for unnecessary tests. An estimated 12.1 million people in the United States will have Afib by 2030; Afib increases the risk of stroke, heart failure, and death, and is one of the few cardiac conditions that continue to rise.(1) “We must give the clinician more effective diagnoses, while at the same time increasing confidence in our healthcare technology systems with respect to the accuracy of the same patient data,” expressed Stuart Long, CEO of InfoBionic, a provider of ambulatory cardiac monitoring services.

Impact of Remote
Patient Monitoring on Afib

Afib is a “fluttering feeling that can point to a quivering heart muscle, a notable skipped beat as the mark of a palpitation, and a racing heart rate that sparks other discomforts.” (2) With the rise of remote patient monitoring (RPM) as an effective and economical modality to treat and monitor patients, false positives continue to rise to generate a lack of confidence in the accurate clinical data captured through RPM. False positives can overwhelm the clinician and result in the increased use of resources and downstream costs, and false negatives could have detrimental clinical consequences.(3) 

Without a reliable RPM supported by powerful AI solutions, healthcare payers experience higher costs. Heart disease takes an economic toll, as well, costing the nation’s healthcare system $214 billion per year and consuming $138 billion in lost productivity on the job. (4) The cascading effect of false positives run the gamut of the human experience—from the physical and emotional health of the patient to the added out-of-pocket expenses of unnecessary and avoidable tests.

The increased risks of hospital readmissions at a time when healthcare systems are overtaxed and understaffed adds another factor of what could have been an unneeded situation. “InfoBionic AI has all but eliminated the need for physicians to deal with false positives. In fact, 100% of Atrial Fibrillation events longer than 30 seconds are detected accurately (true positive) by InfoBionic’s AI system(6),” said Long.

By
leveraging cloud computing with continuous arrhythmia monitoring to create a
reliable platform with accurate data collection, an ambulatory cardiac monitor,
such as the MoMe® Kardia device, optimizes AI solutions,
allowing for consistency in the treatment. Integrated sensor measures have been
shown to predict heart failure and might have the potential to
empower patients to participate in their own care.(5) Offering
24-hour monitoring through RPM technology that reduces false positives leads to
the patient becoming more comfortable with the RPM service, which increases the
likelihood the patient will adopt the practice of self-care well into the
future. Cardiac patients with pulmonary or electrolyte problems may need
continuous cardiac monitoring to screen for arrhythmias.

A primary feature of our MoMe® Kardia is its ability to leverage technology in a way that makes physicians feel more confident via analysis precision that verifies detected cardiac episodes through the algorithm,” said Long. Another distinct advantage is the ability to provide 6 lead analysis instead of the 1 or 2 leads provided by other systems. This affords the physician a much better view of each heartbeat, thereby increasing physician confidence in the accuracy of diagnosis.

The
AI
provides valuable clinical statistics that guide treatment with the best
patient outcomes. As the leading provider to collect every heartbeat and
transmit it to the cloud in near real time, explains Long, InfoBionic’s AI
algorithms are informed by over 15 million hours of electrocardiogram (ECG)
collected from the entire patient population. With full disclosure transmission
that allows AI algorithms to run on powerful servers in the cloud, the system
utilizes much more intensive processing than could be accomplished on other
patient-worn devices. Multiple patented algorithms are run concurrently on the
ECG stream, each with superior performance on a variety of clinical conditions.

RHYTHM AI cleared for large trial of atrial fibrillation mapping tool

UK-based RHYTHM AI is to go ahead with a larger clinical trial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication.

Antiarrhythmic drugs are standard therapy but they often only work for around 18 months, after which time a catheter ablation procedure is necessary to isolate the cause of the electrical abnormality that is the cause of the disease.

The ablation procedure works by using small burns to isolate the vein causing the irritation that is disrupting the electrical pathways in the heart.

RHYTHM AI’s STAR Mapping uses novel computer algorithms to identify the causes of atrial fibrillation, using 3D mapping equipment to inform the ablation procedure.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given the go-ahead for the company to proceed with its ‘ROCSTAR’ clinical trial to further test the system as a potential treatment for persistent AF.

The company said that in a single centre study published in May last year, 80% of patients treated in a single procedure using STAR Mapping were free of AF without use of anti-arrhythmia drugs at an average of 18.5 months follow up.

This compares with a study showing 48% of patients from AF at 18 months follow-up without use of anti-arrhythmic drugs using standard 3D mapping technology.

RHYTHM AI will expand the research, using a multi-centre clinical trial designed to be a ‘real-world’ evaluation of the STAR Mapping System as a potential treatment for patients undergoing cardiac ablation procedure for persistent AF.

The randomised trial will recruit 177 patients in up to 15 UK centres and follow the patients to evaluate freedom from AF at 12 months follow up.

A control group of 59 patients will receive the standard pulmonary vein isolation ablation procedure, while a study group of 118 patients will receive a pulmonary vein isolation procedure by guided further ablation using STAR Mapping.

The primary goals are freedom from AF without anti-arrhythmia drugs at 12 months and response to STAR guided ablation during the procedure – either a slowing or termination of AF.

Clinical development of the system got off the ground last year when the company announced the closure of a £2.15m financing round.

This was led by an affiliate of Rinkelberg Capital Ltd, a private wealth management firm based in London, as well as investment from founders.

Developed at the city’s St Bartholomew’s Hospital, the system was developed by a team including London-based cardiologist Richard Schilling.

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AstraZeneca, Eko Collaborate to Advance Innovation Around Heart Failure

FDA Breakthrough Status Granted for Heart Failure Algorithm by Eko

What You Should Know:

– Eko today announced a global collaboration with
AstraZeneca to accelerate the development of digital health tools for the
earlier screening of cardiovascular diseases, including heart failure. 

– Through the collaboration, AstraZeneca and Eko will explore accelerating the development of Eko algorithms, enhancing clinical trials with Eko technology, and potentially building new heart failure detection solutions.


Eko, a digital health company building AI-powered screening and telehealth solutions to fight cardiovascular disease, today announced with AstraZeneca to accelerate the development of digital health tools for the earlier screening of cardiovascular diseases, including heart failure. Through the collaboration, AstraZeneca and Eko will explore accelerating the development of Eko algorithms, enhancing clinical trials with Eko technology, and potentially building new heart failure detection solutions.

Why It Matters

Heart failure is one of the leading causes of morbidity and
mortality, affecting approximately 64 million people worldwide. Heart failure
happens when the heart cannot pump enough blood into the body and is most
commonly detected by echocardiogram imaging tests that are not normally
conducted during a physical exam. Because of the limited access to
echocardiography or other diagnostic tests, heart failure is frequently
diagnosed late, making life-prolonging treatment more challenging. Heart
failure remains as fatal as some of the most common cancers and is the leading
cause of hospitalization for those over the age of 65, representing a
significant clinical and economic burden.

Eko’s AI-Powered telehealth platform for virtual pulmonary
and cardiac exams, providing clinicians within-person level exam capabilities
during video visits. The platform is already deployed by more than 200 health
systems for telehealth, the platform goes beyond standard video conferencing to
facilitate stethoscope audio, ECG live-streaming, and FDA-cleared
identification of atrial fibrillation (AFib) and heart murmurs.

“Eko was founded to provide a better way to understand our heart and lung health and to improve cardiopulmonary care for patients through digital technology and novel algorithms,” said Connor Landgraf, CEO and co-founder of Eko. “Eko’s collaboration with AstraZeneca will allow us to expand the capability of our technology, generate real-world data, and explore disease management solutions while leveraging AstraZeneca’s global expertise and existing relationships across the treatment continuum for heart failure.”

Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

FDA Breakthrough Status Granted for Heart Failure Algorithm by Eko

What You Should Know:

– The National Institutes of Health (NIH) has granted next-generation
cardiac AI company Eko an award totaling $2.7 million to support continued
collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute

– The grant will focus on validating algorithms and help
more accurately screen for heart murmurs and valvular heart disease during
routine office visits with Northwestern Medicine.

– By incorporating data from tens of thousands of heart
patterns into Eko sensors and algorithms, clinicians will have
cardiologist-level precision in detecting subtle abnormalities from normal
sounds.


Eko, a digital health company
building AI-powered screening
and telehealth solutions to
fight cardiovascular disease, today announced it has been awarded a $2.7
million Small Business Innovation Research (SBIR) grant by the National
Institutes of Health (NIH). The grant will fund the continued collaborative
work with Northwestern Medicine Bluhm Cardiovascular Institute to validate
algorithms that help providers screen for pathologic heart murmurs and valvular
heart disease during routine office visits.

Eko and Northwestern first announced their collaboration in
March 2019 to provide a simpler, lower-cost way for clinicians to identify
patients with heart disease without the use of screening tools such as
echocardiograms which are typically only available at specialty clinics. By
incorporating data from tens of thousands of heart patterns into the
stethoscope and its algorithms, clinicians will have cardiologist-level
precision in detecting subtle abnormalities from normal sounds.

“Cardiovascular disease is the leading cause of death in the U.S., and valvular heart disease often goes undetected because of the challenge of hearing murmurs with traditional stethoscopes, particularly in noisy or busy environments. A highly accurate clinical decision support algorithm that is able to detect and classify valvular heart disease will help improve accuracy of diagnosis and the detection of potential cardiac abnormalities at the earliest possible time, allowing for timely intervention,” said James D. Thomas, MD, director of the Center for Heart Valve Disease at Northwestern Medicine and the clinical study’s principal investigator. “Our work with Eko aspires to extend the auscultatory expertise of cardiologists to more general practitioners to better serve our patient community, playing a pivotal role in growing the future of cardiovascular medicine.”

Recent FDA Clearance and Telehealth Platform Launch

This recognition comes on the heels of several key company
milestones, including the clearance
of Eko’s cardiac AI algorithms by the U.S. Food and Drug Administration and the
launch
of Eko’s AI-powered telehealth
platform. Eko’s ECG-based deep learning algorithm, developed on a large
clinical dataset in collaboration with the Mayo Clinic, can help efficiently
identify signs of possible heart failure in patients.

Eko’s AI-Powered telehealth platform for virtual pulmonary and cardiac exams, providing clinicians within-person level exam capabilities during video visits. The platform is already deployed by more than 200 health systems for telehealth, the platform goes beyond standard video conferencing to facilitate stethoscope audio, ECG live-streaming, and FDA-cleared identification of atrial fibrillation (AFib) and heart murmurs.