Apple Watch isn’t being too closely, err, watched. Photo: Apple
The Food and Drug Administration is in a tough spot when it comes to health-tracking wearables. As the U.S. government agency in charge of regulating medical devices, it can’t promote health-oriented technology that doesn’t do what it claims, but it also doesn’t want to stifle innovation at a time when Silicon Valley is finally turning its attention to the field.
That’s why, according to a new report, the FDA is giving the tech industry, and particularly tech giants like Apple, leeway to develop new products without aggressive regulation.
While some reports are claiming that Apple is still finalizing the specifications for its first generation iWatch ahead of the supposed October launch, another set of reports — supposedly backed up by insider sources — put forward another theory.
With rumors of a new Apple-made “fitness app” coming to iOS 8, secret meetings with the FDA, and murmurs of more sleep and fitness experts joining the Apple ranks, the iWatch rumors are heating up on this week’s CultCast! Plus, a classic Nintendo game makes its way to iOS; Microsoft says goodbye to the one and only Steve Ballmer; and new job openings in Cupertino could mean big upgrades in battery life for future MacBooks…
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The FDA has gone after Biosense, a health startup that makes uCheck, an automated urine analyzer sold directly to end customers. You pee on a strip then use the uChek iPhone app to take a picture and analyze the contents of your urine for health info like glucose. Biosense claims that it can help detect up to 25 diseases, like diabetes, pre-clampsia, and urinary tract infection.
A letter has been sent to Biosense from FDA about its home kit + iPhone app product asking why Biosense hasn’t gotten uCheck officially sanctioned by the government.
AliveCor’s Veterinary Heart Monitor for the iPhone helps vets diagnose heart disease in dogs, cats, and horses.
What do you do if you’re a medical technology startup while waiting for the FDA to approve your flagship iPhone-based product?
If you’re AliveCor, you launch a veterinary version of it.
The product in question is AliveCor’s iPhone ECG heart monitor, which the company showed off nearly two years ago, at the CES in 2011. The device allows a medical professional to assess a patient’s heart rhythm, providing more data than a stethoscope or manual check of their pulse. Although the device has broad potential, it has yet to be approved by the FDA.