AliveCor touts high precision AF detection, AI-powered hyperkalemia detection in KardiaBand studies

AliveCor this week announced results from two studies of its Apple (NSDQ:AAPL) smartphone-connected KardiaBand personal electrocardiogram device, touting the bands ability to detect atrial fibrillation and its ability to detect high potassium levels.

Results from the studies, which were presented this week at the American College of Cardiology’s 67th Annual Scientific Session, provide more support to the usefulness and validity of the band as a cardiovascular health monitor, AliveCor CEO Vic Gundotra told MassDevice.com in an interview.

“Doctors will read healthcare news, but until once it’s been peer reviewed in a study, that’s when you start to see the tide turn,” Gundotra said. “We’re humbled by the cardiology community’s acceptance of AliveCor and we’re humbled that our latest innovation with the Apple Watch has gotten this kind of response.”

The first study, performed at the Cleveland Clinic and accepted for publication by the Journal of the American College of Cardiology, aimed to examine whether the KardiaBand could differentiate between atrial fibrillation and normal heart rhythm at a level similar to standard-of-care 12-lead EKGs, the Mountain View, Calif.-based company said.

“It is the first time the Apple Watch has ever been in a peer reviewed, published journal, a prestigious journal,” Gundotra said. “Cleveland Clinic compared the Kardia band with the Apple Watch, our combined solution, against a standard 12-lead EKG, which is what all doctors use hospital settings.”

Results from the study indicated that the KardiaBand was able to detect AF and normal sinus rhythm with comparable rates to those interpreted by physicians, and was able to correctly interpret AF versus normal sinus rhythm with a 93% sensitivity and 84% specificity. When physicians reviewed the KardiaBand recordings, sensitivity raised to 99%.

“We couldn’t be more thrilled with the outcome,” Gundotra said.

In the second study, researchers looked to explore whether the band, paired with a new artificial intelligence technology, could non-invasively detect high potassium levels – a condition known as hyperkalemia.

“Hyperkalemia kills people. It is a condition where an individual has too much potassium, and when potassium levels get too high, cells cannot conduct electricity correctly. As you can obviously imagine, the cells that are the most important to you that are unable to conduct electricity reside in your heart, and the moment you get hyperkalemic, your heart goes into a dangerous arrhythmia,” Gundotra said. “Today the only way to test for hyperkalemia is a blood test.”

The research, performed in collaboration with the Mayo clinic, examined over data points from more than 2 million EKGs alongside 4 million serum potassium values collected between 1994 and 2017 alongside prospective data from the AliveCor EKG device to develop an AI algorithm to detect hyperkalemia.

Results indicated that the AI platform was able to detect hyperkalemia with an accuracy ranging between 90% and 94%.

Gundotra is hopeful that future generations of the KardiaBand will feature the ability to detect hyperkalemia, alongside other applications aiming to improve cardiovascular health monitoring.

“The idea is that one day, you will simply be able to touch the Kardia band on an Apple Watch and know that you’re getting into a dangerous hyperkalemic state and get treated. The lives we could save would be amazing,” Gundotra said. “This is kind of the dream of artificial intelligence.”

Last November, AliveCor won FDA clearance for its KardiaBand device, with indications for monitoring for early signs of atrial fibrillation.

Initially introduced in March 2016, the KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.

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ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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A roundup of digital health deal flow this week

Amid the uncertainty that House Republicans’ version of healthcare reform and the Trump administration’s budget proposal have stirred, it’s been a busy week for digital health deals from mergers and acquisitions to fundraises.  There were at least four M&A transactions spanning care management tools for payers to clinical decision support.

Remote monitoring dominated the fundraise category, with eight companies raising roughly $92 million.

GE Healthcare acquired UK-based wireless fetal monitor device maker Monica Healthcare 

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GE had been a distribution partner for Monica’s Novii wireless patch system since 2015. The patch, which secured 510(k) clearance from the U.S. Food and Drug Administration in 2011, tracks the mother’s heart rate, fetal heart rate, and uterine activity, according to a news release.

This segment of smart devices is particularly interesting because it could improve outcomes for high-risk pregnancies and alert physicians to problems earlier. Airstrip acquired Sense4Baby’s assets in 2014, which included a noninvasive fetal monitoring system. Among the startups in this space are Bloomlife, which recently took part in the SXSW Accelerator finals.

HMS Holdings, which provides services to payers, paid $170 million to buy Eliza Health. The deal adds to HMS’s health and care management analytics footprint, according to a news release. Eliza’s software offering identifies gaps in care and appropriate condition management, quality scores, revenue and cost management, wellness and preventive care. medication adherence, and member satisfaction and retention, the release noted. Eliza also uses smart profiling as a way to determine the best form of communication to reach health plan members. Eliza’s approach is intended to improve cost savings for insurance companies not only by making their administrative systems more efficient but also by assisting payers in their transformation towards being more consumer friendly.

Traffk, a Los Angeles technology company that wants to change how insurance underwriters manage and assess risk, acquired Capsci Health, a company press release noted. Capsci personalizes health plan members’ benefits, gives them direct access to their plan’s benefits, ID cards, preferred providers and telemedicine.

First Databank (FDB), a drug clinical decision support business that’s part of the Hearst Health Network, acquired Polyglot Systems — a healthcare company focused on improving health literacy for people with a limited proficiency in English. FDB and Polyglot had established a partnership in 2015, so an outright acquisition is not so surprising.

Fundraises

CareDox, a health IT business that developed an electronic health record system for schools, closed a $6.4 million Series A round. Digitalis Ventures led the round and First Round Capital, Giza Venture Capital, TEXO Ventures, and Prolog Ventures also took part. The CareDox currently works with 2,000 schools but it also wants to expand its healthcare provider customer base.

Diabetes management business Livongo closed a $52.5 million round co-led by General Catalyst, an existing investor, and international investment company Kinnevik. Other investors included Microsoft Ventures, American Investment Holdings, and EDBI, a Singapore-based fund whose portfolio includes WellTok, GoBalto, and Sotera Wireless.

Although MedCity News previously reported on Cohero’s latest fundraise to allow for additional capital in its oversubscribed Series A round in February, it was officially announced this week. One new wrinkle included the addition of two new strategic investors in the connected device developer tracking lung function — Samsung NEXT and Omron Healthcare.

Babel Health, which develops risk adjustment software for health plans, raised $1.5 million in a bridge round, according to a news release.

EvidenceCare, a Nashville-based clinical decision support startup raised $2 million in a convertible B note. The company provides a way for healthcare providers to find and digest the latest treatment guidelines.

AliveCor raised a $30 million Series D round from Mayo Clinic and Omron Healthcare to support the ECG device and app developer’s addition of artificial intelligence to support stroke prevention.

Sharecare received an undisclosed amount from strategic investor Hawaii Medical Service Association, an independent licensee of the Blue Cross and Blue Shield Association and Hawaii’s leading health plan.

CarePredict, a Fort Lauderdale wearable developer that aims to help seniors by monitoring their movements, added $500,000 from venture investor Las Olas Venture Capital, according to a news release from the venture capital firm. Satish Movva, the founder, explained that he started the business to avoid minor health issues with his aging parents escalating into serious, costly hospitalizations. The idea is by establishing a baseline for the user’s routine, family or professional caregivers receive text message alerts if the wearable detects they are walking slower, spending more time sitting or in bed. It also keeps a log of daily activity.

Photo: atibodyphoto, Getty Images

AliveCor launches clinical app with AI function for early detection of AFib to prevent stroke

Screenshot from AliveCor Kardia Pro app for clinicians from AliveCor.

AliveCor, which has developed an FDA-cleared smartphone-enabled ECG device, has launched a clinician-facing app using artificial intelligence to pick up signs of atrial fibrillation earlier, according to a company news release. It’s an interesting development for the business because it can alert physicians to patients with an elevated risk of having a stroke.

The Kardia Pro app is for clinical use. But the goal is to analyze data from patients that includes weight, activity and blood pressure with AI to personalize the heart profiles of each patient, the news release said.

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Last year, AliveCor partnered with Omron Healthcare to add Omron’s hypertension screening capabilities to AliveCor’s app.

An estimated 795,000 people suffer a stroke each year, the majority of them for the first time. If you factor in hospitalization, medications and time off of work, strokes cost the U.S. roughly $33 billion each year, according to data from the Centers for Disease Control.

AliveCor also closed a $30 million Series D round led by Omron Healthcare and Mayo Clinic. The funding will be used to speed up innovation in heart health and grow the business.

The launch of the company’s Kardia Pro app is an important milestone for AliveCor. But at a time when the hype around AI has reached a fever pitch, clinical validation will be critical to demonstrate how effective the company is at spotting early signs of life-threatening conditions such as stroke and whether these interventions improve patient outcomes.

Features Photo: Bigstock