AliveCor has FDA-approved heart tracker for Apple Watch

“AliveCor, a startup that builds heart-monitoring sensors for smartphones, is building sensors for another mobile device: The Apple Watch,” Mark Bergen reports for Re/code.

“AliveCor is also putting out a new app replete with speech-recognition features that, paired with the watch sensor, the startup hopes will replace the cumbersome, expensive devices for patients with pressing heart conditions,” Bergen reports. “And the company claims it’s releasing each with the seal of approval from the Food and Drug Administration at a time when other medical devices and bio-tech firms have hit regulatory blockades with the agency (or simply run afoul of it).”

Bergen reports, “‘AliveCor sits on the other side of the FDA line,’ CEO Vic Gundotra told Re/code. ‘We are not a fitness product. This is not a toy. We’re talking about people’s lives.'”

Read more in the full article here.

MacDailyNews Take:

SEE ALSO:
AliveCor Apple Watch ultrasonic ECG heart monitoring band planned for 2016 launch – October 16, 2015
AliveCor launches new iOS-only app to auto detect atrial fibrillation in an ECG recording – September 29, 2014

6 Comments

  1. Doesn’t even have a release date. Or FDA approval for the band, though they are seeking it. Sounds to me like they’re concerned Apple will come out with something similar within weeks.

    1. It’s not uncommon to announce something like this pending FDA approval, when you are pretty confident about getting that approval. We find out all of the time about medications before they get FDA approval. It’s smart to get the word out so when FDA approval happens you have waiting customers.

      I don’t think they have to worry about Apple doing an EKG band; Apple already said they will leave the FDA approved medical products to other companies.

      I would say that perhaps they announced this, because they are going to be at the Apple media event on Mar 21. I wouldn’t at all be surprised to see Apple highlight this and other Apple Watch accessories and apps.

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