AliveCor said today that the FDA cleared its KardiaBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.
First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.
AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the correlation between heart activity and physical activity using data from heart rate and activity sensors in the watch. The app prompts users to capture an ECG reading when heart rate and activity are out of whack either with KardiaBand or AliveCor’s portable KardiaMobile device.
“KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” AliveCor CEO Vic Gundotra said in prepared remarks. “These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage afib, a leading cause of stroke, and other serious conditions.”
“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” added Dr. Ronald Karlsberg of Cedars Sinai Heart Institute and UCLA’s School of Medicine UCLA in Los Angeles. “Today, [ECGs] are available only in offices and hospitals, using complex equipment, and usually only after a life threatening event, for example a stroke. With an EKG device on the wrist, afib can be detected wherever the patient is, 24 hours a day. In randomized research trials, KardiaMobile, the first AliveCor [ECG] device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care.”
The KardiaBand accessory goes for $199 and requires an annual $99 subscription to AliveCor’s Premium service, the company said.
Over- and mis-diagnosis a concern
Physicians expressed concern that the KardiaBand technology, potentially useful as a long-term monitoring tool in already-diagnosed patients, could lead to over- and mis-diagnosis.
“The key is the rhythm alert which triggers the user to grab an ECG. It is interesting and I could see it used as a long-term monitor in lieu of, say, an implantable loop recorder. There is space for this. If the technology works, it could be great,” Dr. Ethan Weiss of the University of California-San Francisco told CardioBrief. “But in people with cryptogenic stroke or post-[transient ischemic attack] or even [at] very high risk (say mitral stenosis or extremely high CHA2DS2-VASc scores), this could be a very useful tool. Of course, I expect it will be used by many people in whom there is no indication, and that will lead to a lot of cardiologists trying to sort through a LOT of data they don’t understand.”
“Measuring things is not therapy,” added Mayo Clinic’s Dr. Michael Joyner. “So in terms of patient care applications, if this is not linked to a coherent way to deal with and act on the data, then any assumptions about better outcomes are premature. The well-done [randomized controlled trials] on things like [congestive heart failure] and home monitoring have not been especially impressive.
“It is easy to envision a cascade of over-diagnosis stemming from more monitoring,” Joyner told the website. “The evidence that wearables consistently motivate positive and durable behavior change over time is pretty thin. … Better technology per se is not going to solve complex systems and behavioral challenges.”
Apple plans huge afib study
Also today, Apple (NSDQ:AAPL) released its Apple Study app, aiming to entice Apple Watch users into signing on for a study of atrial fibrillation, using the watch’s green LED lights and light-sensitive photodiodes to detect the amount of blood flowing through the wrist.
The study, with partner the Stanford University School of Medicine, will alert users when irregular heartbeats are detected and provide free consultation with study doctors and an ECG patch for additional monitoring. The study is open to users age 22 or older with an Apple Watch 1 or later devices, the tech giant said.
“Every week we receive incredible customer letters about how Apple Watch has affected their lives, including learning that they have afib. These stories inspire us and we’re determined to do more to help people understand their health,” COO Jeff Williams said in prepared remarks. “Working alongside the medical community, not only can we inform people of certain health conditions, we also hope to advance discoveries in heart science.”
“This might seem like a simple study, but we think this is a really special time,” Williams told CNBC. “Hopefully we can save a lot of lives.
“It has been a very organic journey,” he said. “We didn’t wake up one day and say ‘we did iPhone, then we did iPad and let’s knock out health next.'”
