FDA Approves ECG Band For Apple Watch

(Updated)

—Kardia Band is the first FDA approved medical accessory for the Apple Watch.

The FDA has cleared a band for the Apple Watch that records an ECG. According to AliveCor, the Kardia Band is the first medical device accessory cleared 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. AliveCor says the band will record a clinical-grade ECG in 30 seconds.

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. The program, according to an AliveCor spokesperson, “leverages sophisticated artificial intelligence to detect when a user’s heart rate and physical activity are out of sync, and prompts users to take an EKG in case it’s signaling possible abnormalities like AFib.”

The Kardia Band will sell for $199. This includes the ability to record unlimited ECGs and to email the readings to anyone. The SmartRhythm program will be part of the company’s KardiaGuard membership, which costs $99 a year. KardiaGuard stores ECG recordings in the cloud and provides monthly summary reports on ECGs and other readings taken.

Kardia Band is similar in function to AliveCor’s Kardia Mobile, a small device which interfaces with smart phones to display and record ECGs.

In an interview, AliveCor founder David Albert, a cardiologist, said that Kardia Band and Kardia Mobile are often recommended to atrial fibrillation patients by their cardiologists to monitor their condition. In other cases, it has been used in people with palpitations, leading to a supraventricular tachycardia diagnosis in some cases. Another use is in an Afib patient prior to cardioversion, avoiding the “complete waste of time” for patient and doctor alike when the patient arrives in sinus rhythm.

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.

Ethan Weiss (UCSF) observed that the band provides the same functionality as the earlier phone-based device. “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.”

Weiss expressed concern over the potential for misdiagnosis or overdiagnosis if it is used to screen for stroke risk in the general population. “That is nonsense,” he said. “But in people with cryptogenic stroke or post TIA [transient ischemic attack] or even 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.”

Michael Joyner (Mayo Clinic) offered a similar 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 expressed concern about the effect the consumer devices will have on the “worried well.” How will they handle information about “funny” heartbeats? “It is easy to envision a cascade of overdiagnosis stemming from more monitoring,” he said.

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.”

Update:

James Stein (University of Wisconsin) offered the following comment:

Cool device. The problem it solves is that some people have expendable income and there are other people who want that money. May people with expendable income have health-related anxiety, so this product enables their desire to spend money and achieve a temporary but false piece of mind, since random monitoring has not been proven to prevent any adverse events or improve health outcomes, and is very unlikely to based on previous research. From the physician standpoint, we already have wearable monitors that offer multi-lead recordings and sophisticated analysis that are prescribed under medical supervision and usual covered by insurance. As anyone who has ever owned a heart rate monitor and every doctor knows, extra beats and a variety of causes of heart rate “irregularity” are common but lead, in susceptible patients, to anxiety that gets transferred to their doctor, who inevitably will order more tests. The big winners, other than Alive Cor, will be hospitals, monitoring companies, and makers of DOACs. Maybe trial lawyers, too. Sigh.

See also:

• Steve Jobs Rejected The First Medical App In 1977