AliveCor Gundotra

AliveCor, led by entrepreneur Vic Gundotra, has produced an EKG-reading Kardia Band that has received clearance by the FDA. It is the first Apple Watch accessory to receive such clearance. (AliveCor photo)

Led by Indian American entrepreneur Vic Gundotra, a former Google employee, digital health company AliveCor has produced an accessory that is the first of its kind on the Apple Watch to receive Food and Drug Administration clearance.

Gundotra says the FDA has approved its EKG band accessory, the Kardia Band, for the Apple Watch, adding that the band is the first Apple Watch health accessory to get FDA clearance, according to a Fast Company report.

The band attaches to the Apple Watch like any other replaceable watch band. The user rests a finger on the sensor pad embedded in the band, allowing an EKG reading to be taken, the report said.

The band transmits its EKG reading to the Apple Watch where it’s displayed in real time as a moving waveform. When the 30-second EKG is finished, the user can view it on their phone or easily send the results as a PDF to their physician, according to the report.

While doctors can diagnose a plethora of diseases using data retrieved from an EKG reading, AliveCor can only record the EKG and advise whether its normal or possibly indicative of atrial fibrillation, the publication said.

Gundotra says the Kardia Band will be useful to younger people who have diagnosed heart conditions, and by people in their 40s or older who have congenital heart disease in their families, it added.

The U.S.-based version of the Kardia Band is actually its second version. The preliminary band was released in Europe last year. The report noted that the new, FDA-approved band is much different than the European one.

The second version includes SmartRhythm, a set of machine learning algorithms that run on the Apple Watch and use real-time and historical activity and sensor data to predict an acceptable heart rate range for the user throughout the day, according to the report.

According to the report, Gundotra, who brought with him a group of other ex-Google employees to AliveCor, are working to fulfill a mission, and not just make money.

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