AliveCor gets first FDA nod for an Apple Watch accessory

AliveCor has gained clearance to sell a medical device accessory for Apple Watch. The regulatory nod covers AliveCor’s KardiaBand, a device that clips onto Apple’s smartwatch and performs EKG readings.

Users of the $199 AliveCor device and accompanying $99-a-year service replace the wristband on their Apple Watch with KardiaBand. Machine learning algorithms, dubbed SmartRhythm, then sift through data gathered by Apple Watch’s sensors to establish a normal band of heart rate activity. If the wearer’s heart rate deviates from these historic norms, the app directs the user to take an EKG.

This is where the band itself comes in. The user places a finger on a sensor built into the strap. The band then performs an EKG, also known as an electrocardiogram, to assess whether the electrical impulses that modulate cardiac contractions are firing properly. The resulting 30-second waveform is shown on the Apple Watch screen, after which the user can share it with their doctor as a PDF.

Aspects of the technology are the same as the credit card-sized device, KardiaMobile, AliveCor already sells for use with smartphones. But the incorporation of the Apple Watch sensors and data into the process stands to change when and why users decide to take an EKG reading.

“A lot of my patients already use the credit card sensor, but they don’t know when to take an EKG, so they just do it when they feel light-headed or dizzy,” Eric Topol, M.D., a cardiologist at Scripps, told FastCompany.

The problem with that reactive, symptom-triggered approach is atrial fibrillation can occur without warning. KardiaBand seeks to fix the disconnect between how a patient feels and their underlying condition by monitoring heart rate data captured by Watch for signs of atrial fibrillation. When the app spots a red flag, it tells the user to perform an EKG.

“If you can direct them when to do the EKG it’s going to markedly increase the number of EKGs taken,” Topol said.

RELATED: AliveCor discloses EKG band for Apple Watch, upgrades existing a-fib app

The big question now is whether this more objective approach to assessing when an EKG is needed will translate into improved outcomes for patients. AliveCor has clinical trial data showing its smartphone-based EKG outperformed routine care. In theory, the Apple Watch-based approach should improve on that product, for the reasons outlined by Topol, but that hypothesis is yet to be tested in the wild.

For the broader digital health sector, the important thing is AliveCor has gained clearance to start finding out how its device performs in the real world at all. AliveCor hustled through the regulatory process far faster in Europe than in the U.S. When AliveCor unveiled the device in March 2016, it talked up the prospect of “late spring” availability. That target came and went as AliveCor grappled with the FDA review process.

Vic Gundotra, the ex-Googler who runs AliveCor, told TechCrunch getting the device to market was “one of the hardest things I’ve ever done in my life.” Under the leadership of Scott Gottlieb, M.D., the FDA may provide an easier route to market for companies that try to follow in AliveCor’s wake. But having put in the hard yards, AliveCor has the field to itself for now.