|AliveCor's EKG wrist band for the Apple Watch--Courtesy of AliveCor|
AliveCor has an electrocardiogram wrist band that's worn with the Apple Watch. It's been submitted to the FDA, but a launch is pending a 510(k) clearance by the agency. By simply touching the band, the wearer can capture an EKG that's then analyzed by a machine-learning algorithm to detect atrial fibrillation, a common cause of cardiac arrhythmia and a major cause of stroke.
The user can send a relevant EKG to their doctor, along with a voice memo regarding symptoms and any relevant external factors via the Apple Watch. Dubbed the Kardia Band, it also integrates with the Apple Health app to have EKG data alongside information such as steps and calorie intake.
"People have incredible amounts of data that they are carrying around on their wrist. Now, you can have our EKG device right on your wrist when you need it. We required a technical breakthrough--to build it and make it this small," AliveCor CEO Vic Gundotra told FierceMedicalDevices in an interview.
It's almost impossible to tell when or where atrial fibrillation will strike. The band may offer a continuous monitoring option that would otherwise require physicians to prescribe a Holter monitor worn for 4 days or a chest patch like the one from competitor iRhythm Technologies that can be worn for up to two weeks. Both entail after-the-fact analysis of the data to try to better understand a-fib activity in a particular patient.
In addition to the band, AliveCor has rebranded its existing EKG device that attaches to the back of smartphones and tablets as Kardia Mobile. The accompanying app has also been upgraded to enable the patient to make a voice recording to describe symptoms and other relevant information that can accompany an EKG sent to a physician. It's also now integrated with Apple HealthKit.
Although getting EKG information to a physician may be simple enough with either Kardia device, it remains a challenge to get it routinely integrated into patient medical records.
"There are a number of reputable health systems that have incorporated our product into their work flow. Not all recordings are worthy of getting into a patient record. But those a-fib results can be put into the file along with their notes," described Gundotra. "One of the biggest challenges is that there are over 225 different EHR systems in the U.S. healthcare system. Becoming interoperable with them is a big challenge."
- here is the announcement