Apple just got the approval it needs from the U.S. Food and Drug Administration to make the latest AirPods Pro into medical-grade hearing aids.
Once Apple releases a software update for the wireless earbuds, they’ll be able to help those with mild to moderate hearing loss.
For the first time, the U.S. Food and Drug Administration (FDA) qualified a digital technology — Apple Watch’s AFib History feature — for a special research program. AFib, or atrial fibrillation, is a type of abnormal heart beat associated with heart attacks.
Apple Watch’s AFib History now qualifies for FDA’s stringent Medical Device Development Tools (MDDT) program. The program says which tools research sponsors can choose from to help develop and evaluate medical devices.
After Apple warned users of implanted medical devices to avoid iPhone 12 and MagSafe accessories, the U.S. Food and Drug Administration weighed in to say that the danger to pacemakers and defibrillators from magnets built into electronic devices is low.
The long-awaited ECG app is almost available on Apple Watch Series 4 (if you live in the U.S.) with watchOS 5.1.2.
It is the first wearable of its kind to offer this functionality, which promises to help uses detect atrial fibrillation — the most common form or irregular rhythm. Irregular heart rhythm notifications have also landed on Series 1 devices and later.
Apple Watch buyers will be granted an extended return period if they decide to return their wearable for reasons related to upcoming heart health features.
Apple usually gives shoppers 14 days to return a purchase, but an internal document reveals that some will have up to 45 days to return a Watch — as long as it’s for the right reasons.
Apple Watch Series 4’s incredible ability to offer electrocardiograms (ECG) is one of the biggest reasons to upgrade this year. But you can’t use it yet.
Those in the U.S. will be able to get their hands on the feature before the end of 2018, but for those in other countries, the wait could be a lot longer. If you live in the U.K., you may even have to wait “years,” one report warns.
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.
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.
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.
Apple is developing a “killer” new health device that is scheduled to make its debut in 2017, according to a new report. The device will reportedly monitor heart rate and blood sugar, and will somehow be baked into next year’s iPhone.
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.
And it makes a lot of sense.
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.
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.
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.
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.