FDA Approves ECG Band For Apple Watch
Kardia Band
The FDA has approved a band for the Apple Watch that allows users to take a 30 second EKG right on the wrist. The kardia Band is the first medical device accessory approved by the FDA for the Apple Watch. The Kardia Band is activated with a touch of its integrated sensor. It displays the rhythm in real time on the watch face and records the rhythm for later use.
SmartRhythm
AliveCor simultaneously announced the introduction of SmartRhythm, a program for the Apple Watch that monitors the watch’s heart rate and activity sensors and provides real-time alerts to users to capture an ECG with the Kardia Band. KardiaBand product for Apple Watch REQUIRES Premium membership. The cost is $99 a year.
Kardia Mobile
Kardia Mobile is similar in function to AliveCor’s Kardia Band, a small device which interfaces with smart phones to display and record ECGs. Kardia Mobile sells for $99. KardiaMobile does not require any subscription. EKGs may be printed or emailed an unlimited number of times right after you take the recording.
Comments
“KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” said Vic Gundotra, CEO, AliveCor. “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.”
Neither the ECG watch band nor cloud storage membership require a prescription or are eligible for insurance reimbursement. However, if a doctor writes a prescription for the device, then patients can use their medical savings account to pay for it.
Albert said that he believes the AliveCor products have the potential to transform medical care, bringing more information to both patients and physicians. But, he conceded, no benefits in outcomes have been demonstrated. AliveCor is now supporting research that he hopes will help show these benefits.
Michael Joyner (Mayo Clinic) offered a warning. “Measuring things is not therapy,” he pointed out. “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 RCTs [randomized controlled trials] on things like CHF [congestive heart failure] and home monitoring have not been especially impressive.”
Joyner also took issue with the common belief (or hope) that these devices can help people who want to get healthier. “The evidence that wearables consistently motivate positive and durable behavior change over time is pretty thin,” he said. “Better technology per se is not going to solve complex systems and behavioral challenges.”