Apple Watch Series 4 ECG should pave way for more medical gadgets, U.S. FDA says

“The nation’s top medical-device regulator wants to make it easier for other companies to follow Apple Inc.’s lead in integrating products like the Apple Watch’s heart monitor into new consumer gadgets,” John Tozzi reports for Bloomberg.

“‘We want to make the market for consumer medical products accessible to nontraditional manufacturers, or traditional technology manufacturers that haven’t before entered the medical space,’ U.S. Food and Drug Administration Commissioner Scott Gottlieb said in an interview at Bloomberg headquarters in New York on Thursday,” Tozzi reports.

“The FDA approved [Apple Watch Series 4] under a lighter-touch regulatory approach that didn’t require the agency to ‘rip apart the watch,’ Gottlieb said. Instead, the regulator focused on whether the software provided valid information to consumers,” Tozzi reports. “The FDA is talking with other companies about putting new consumer medical products on the market through the same approach, Gottlieb said.”

Read more in the full article here.

MacDailyNews Take: We cannot wait to see how Apple Watch Series 4 ECG performs and if the benefits outweigh the drawbacks overall.


  1. Apple “Watsoned” AliveCor for the new watch. Their EKG watch band works with series 3 watches and does the same thing via a special watch band and has been on sale for some time now.

    Apple has a long record of walking over developers for what Phil claims are “revolutionary” new features, that and copying Android Phones.

    Since the departure of Steve Jobs, Apple has become Microsoft under Stave Ballmer. Iterate and imitate- not innovate.

    1. I’ve been working professionally with Mac software development since the mid 80s. This is not something Tim Cook made up. Apple did plenty of Sherlocking back in the Steve Jobs days and even before that. There’s nothing Microsoft about it.

      The risk of Apple incorporating your product’s features into the operating system has always been a risk but it’s also an opportunity. When they assimilate 80% of your features, that means they are raising customer awareness and building a market for your remaining 20% as a premium product. It just takes some entrepreneurial nimbleness.

    2. I’ve had 3 AliveCor Mobile devices, and they are great at what they do. However, you are mischaracterizing the AliveCor Kardiaband device. It’s not the “same thing”. While it also takes a single-trace EKG, it does it in a completely different way, and it costs $200 in addition to your AppleWatch, and it costs $100 a year in subscription fees. Not to mention it comes only in black. As someone who has had the Kardia Mobile device since it came out and offered to beta test the Band, I did not find the Band a compelling upgrade for what it offered over the Mobile device.

      The AppleWatch ECG’s technology is different, far cheaper, and more convenient to the user. Further, Alivecor had to have known that Apple was working on ECG. It’s an obvious application of technology, given what Apple was already doing with heart rate.

  2. Gottlieb’s comment is somewhat ambiguous as if he did not think through its implications.

    I truly hope that U.S. Food and Drug Administration Commissioner Scott Gottlieb is not hinting that his administration, and Trump in general, are or will support Apple’s competitors to copy Apple products and, should any sue Apple for one reason or another, that administration will either go easy on or side with them!

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