AliveCor aims to deliver FDA-approved heart monitoring for Apple Watch

AliveCor, led by three former Google software development and design gurus, is aiming to do what Apple hasn't with its wearable Watch: provide users with a sophisticated, accurate and federal government-approved heart monitor.

The five-year-old startup, now led by Vic Gundotra, its fourth CEO and former Google+ chief, is also prepping a new speech-recognition app for its Apple Watch heart monitoring sensor, according to a Re/code article.

The device will have full U.S. Food & Drug Administration approval before it hits market, according to Re/code. It will be "medical grade," and a "breakthrough in proactive heart health," according to the product website.

"AliveCor sits on the other side of the FDA line," CEO Vic Gundotra told Re/code. "We think it will become the first FDA-cleared accessory for any smartwatch device. We are not a fitness product. This is not a toy. We're talking about people's lives."

Gundotra, along with Simon Prakash, an ex-Google hardware unit senior leader, and Frank Petterson, a former engineering lead at YouTube, have gotten FDA approval on the algorithm for ECG analysis for the Kardia Band. The device, about the size of a nickel, plugs into the Watch wristband and lets user verbally share data regarding symptoms and deliver a heart rate assessment via email with caregivers.

AliveCor is aiming at the increasing lucrative wearables market as well as the increasing consumer demand for mHealth tools and devices. The healthcare wearable device market is expected to hit $17.8 billion in revenue by 2021 and digital health will be a driver in more efficient, affordable and wide ranging healthcare and wearables, according to a Tractica market forecast.

AliveCor's mobile ECG heart monitor (iECG), which received FDA clearance in late 2012, was determined to be highly effective, accurate and cost effective for determining undiagnosed atrial fibrillation and stroke prevention, according to a 2013 study.

However, Apple has been slow and stumbling since an initial declaration that its Watch would be game-changing mHealth tool. 

For more information:
- read the re/code article
- read more about the Kardia Band

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