Why we should be wary of Apple Watch ‘ultimate’ health guardian claims

By

Apple Watch Series 4
A very useful tool? Yes. The ultimate tool? Let's not get too far ahead of ourselves.
Photo: Apple

One of the Apple Watch Series 4’s massive new features is its electrocardiogram (EKG/ECG) heart rate monitor.

The device is capable of monitoring irregular heart rhythms and reportedly using this to identify potential episodes of atrial fibrillation, a.k.a. AFib. As exciting as the FDA-cleared technology sounds, however, some have expressed their concerns about the tech. A new report cites several concerns — including about Apple’s usual levels of hyperbole.

Apple Watch’s new ECG reader is great, but don’t bet your life on it

By

Apple Watch Series 4
Some things you should know about the FDA clearance of the new Apple Watch's EKG.
Photo: Apple

At yesterday’s iPhone and Apple Watch event, Apple revealed that it has received Food and Drug Administration clearance for the Apple Watch Series 4’s new electrocardiogram feature. In theory, this marks the ascension of the Apple Watch from a wellness health tracker to a full-fledged medical device.

But people shouldn’t be too quick to jump to conclusions about the Apple Watch’s FDA-approval stamp. Adam Masin, a litigator who deals with medical device manufacturers in product liability lawsuits, made a few crucial points on Twitter.

FDA fast-tracks Apple health products

By

Apple Watch Series 2 will still make you stare at their wrists waiting for it to wake, when you should be watching where you are running
The FDA is easing up on digital health tools like Apple Watch.
Photo: Graham Bower / Cult of Mac

The Food and Drug Administration is making it easier for Apple and other tech companies to get health-related products out to the public faster.

Apple will be part of a new pilot program aimed at rapidly advancing the development of digital health applications. If the program works as intended, it could mean we’ll see new Apple Watch applications and other Apple-made health accessories a lot sooner.

FDA is taking a ‘hands-off approach’ to Apple Watch

By

Apple Watch isn't being too closely, err, watched. Photo: Apple
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.

Apple sees mobile health push as ‘moral obligation’

By

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 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.

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

By

cultcast-iPad-Mini-new-logo.jpg

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…

Thanks to Squarespace for supporting this episode! Treat yourself to a brand new website with the help of Squarespace – a drag-and-drop, do-it-yourself site builder with everything you need to create an exceptional website. Head to Squarespace.com to try it for free, and use the offer code “CultCast” to save 10% on any order.

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.


The FDA Is Worried About You Using The iPhone For Urinalysis

By

article-0-18526ACB000005DC-592_634x356

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.

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

By

AliveCor's Veterinary Heart Monitor for the iPhone helps vets diagnose heart disease in dogs, cats, and horses.
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.