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 (in the US). 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.”