All items tagged with "FDA"

Is the FDA making us wait for iWatch?

(Photo: Fuse Chicken)

(Photo: Fuse Chicken)

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.

And it makes a lot of sense.

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Apple sees mobile health push as ‘moral obligation’

Craig Federighi showing iOS 8's Health app to the world at WWDC. (Photo: Roberto Baldwin/ The Next Web)

Craig Federighi showing iOS 8’s Health app to the world last week at WWDC. Photo: Roberto Baldwin/The Next Web

Apple will be working closely with the Food and Drug Administration on future products related to the health industry, according to new information provided by the government.

Back in January, The New York Times reported that Apple had met with the FDA to discuss “mobile medical applications.” The talk was believed to center on the company’s rumored plans for health-tracking software in iOS 8 and maybe even the iWatch. HealthKit and the new Health app were announced at WWDC last week, and an iWatch announcement is expected in October.

Now more of the details from Apple’s meeting with the FDA have been disclosed. Apple said it may have a “moral obligation” to do more with health-related sensors on mobile devices.

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Apple Inches Closer To Health-Tracking Domination On Our Newest CultCast

Cultcast iPad Mini new logo

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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Softly giggle your way through each week’s best Apple stories! Stream or download new and past episodes of The CultCast now on your Mac or iDevice by subscribing on iTunes, or hit play below and let the audio adventure begin.

Apple Inches Closer To Health-Tracking Domination On Our Newest CultCast
Apple Inches Closer To Health-Tracking Domination On Our Newest CultCast

The FDA Is Worried About You Using The iPhone For Urinalysis

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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.

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Waiting For FDA Approval For Humans, This iPhone Heart Monitor Is Helping Pets Instead [Video]

Waiting For FDA Approval For Humans, This iPhone Heart Monitor Is Helping Pets Instead [Video]

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.

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Should the FDA Monitor Health Apps?

Should the FDA Monitor Health Apps?
The Food and Drug Administration (FDA) is proposing guidelines to monitor a “small number of mobile apps.”

Before you start wondering whether the feds are going to jump into your pocket along with your ever-present smartphone, it doesn’t look that way yet.

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