AliveCor’s KardiaBand is first Apple Watch accessory to be cleared by FDA

November 30, 2017

AliveCorMedical wearable device technology has just crossed a threshold: AliveCor (Mountain View, CA) announced today that its KardiaBand has been cleared by FDA, making it the first Apple watch accessory to be classified as a medical device in the United States.

KardiaBand allows Apple Watch users to capture electrocardiogram (EKG) readings anytime, anywhere. Similar in appearance to a replaceable watchband, the KardiaBand contains an embedded sensor. The user places a finger on the sensor pad, and an EKG reading is performed within 30 seconds. Results from the Kardia app are displayed on the face of Apple Watch and can be transmitted as a PDF to a physician.

The device is cleared by FDA to detect atrial fibrillation, the most common heart arrhythmia and a leading cause of stroke. It affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it.

An earlier version of the KardiaBand has been available in Europe since last year.

AliveCor is also introducing SmartRhythm, a new feature within the Kardia app for Apple Watch. SmartRhythm uses artificial intelligence in concert with inputs from Apple Watch's heart rate and activity sensors to continuously evaluate the correlation between heart activity and physical activity. When SmartRhythm detects that heart rate and activity are out of sync, the device notifies users to capture an EKG with KardiaBand, or with KardiaMobile, AliveCor's portable EKG reader.

EKG readings typically are conducted in doctors’ offices and hospitals after a life-threatening event. Wearing a device that alerts you to irregularities in your heart rate and being able to immediately send a readout to your doctor represents a “giant leap in personalized health care,” as one cardiologist noted.

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"KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health," said Vic Gundotra, CEO, AliveCor. "These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage [atrial fibrillation], a leading cause of stroke, and other serious conditions."

Gundotra is a former Google executive who oversaw the development of Google Photos and Google+. For someone who made his fortune in the tech world, navigating FDA regulations was a humbling experience, and required him to “start over” in some ways, he told Fast Company.

He has “found his second act building affordable consumer devices that promote health and even save lives,” writes Fast Company. “He’s surrounded himself with several other ex-Google people at AliveCor who are in the same general place, meaning that making money isn’t the only thing driving their commitment. ‘They’re working for the mission, the AliveCor mission,’ Gundotra said.”

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