Report Claims iWatch Awaiting FDA Approval, Will Feature Blood Glucose and Sweat Sensors

Apple's first-generation iWatch is awaiting certification from the U.S. Food and Drug Administration (FDA) before it enters mass production for a launch this Fall, claims Chinese website Laoyaoba (Google Translate, via GforGames). Citing inside sources, the site claims that Apple has already finalized the design and specifications of the watch, noting that the company is trying to get the device certified as medical equipment.

basis_fitness tracker


It was reported earlier this month that Apple had met with the FDA in December to discuss a number of topics, with some suggesting that Apple might be laying some groundwork for the iWatch. However, a memo issued by the FDA noted that the dialogue merely revolved around its guidance on mobile apps and making sure that the technology industry and regulators are on the same page.

Laoyaoba also claims that the iWatch will come with a number of advanced health sensors, including those that measure heart rate, blood pressure, and blood glucose. Apple has also apparently developed an in-house sweat analysis sensor for the iWatch, which will all work with iOS 8's Health app to track various health metrics.

This information also contrasts a number of past reports that pointed to the iWatch focusing on more simple functionality to make the health-tracking experience more accessible to everyone. While Apple hired a number of personnel with expertise in fields like blood glucose monitoring, it has been noted that such technologies may not make it into the first-generation iWatch, which require a lengthy-approval process from the FDA and complex hardware integration.

Reports from the The Wall Street Journal and Reuters yesterday noted that Apple is also still trying to finalize specifications for the device. Notably, the Wall Street Journal report suggested that the iWatch will ship in "multiple versions", while the Reuters report said that the device will sport a 2.5-inch screen and feature wireless charging and pulse sensing capabilities.

The iWatch is expected to be revealed and launched in October, which was a date reported earlier this month by Re/code.

Related Roundup: Apple Watch 11
Buyer's Guide: Apple Watch (Buy Now)

Popular Stories

iOS 26

15 New Things Your iPhone Can Do in iOS 26.2

Friday December 5, 2025 9:40 am PST by
Apple is about to release iOS 26.2, the second major point update for iPhones since iOS 26 was rolled out in September, and there are at least 15 notable changes and improvements worth checking out. We've rounded them up below. Apple is expected to roll out iOS 26.2 to compatible devices sometime between December 8 and December 16. When the update drops, you can check Apple's servers for the ...
Foldable iPhone 2023 Feature 1

Apple to Make More Foldable iPhones Than Expected

Tuesday December 9, 2025 9:59 am PST by
Apple has ordered 22 million OLED panels from Samsung Display for the first foldable iPhone, signaling a significantly larger production target than the display industry had previously anticipated, ET News reports. In the now-seemingly deleted report, ET News claimed that Samsung plans to mass-produce 11 million inward-folding OLED displays for Apple next year, as well as 11 million...
iPhone 14 Pro Dynamic Island

iPhone 18 Pro Leak Adds New Evidence for Under-Display Face ID

Monday December 8, 2025 4:54 am PST by
Apple is actively testing under-screen Face ID for next year's iPhone 18 Pro models using a special "spliced micro-transparent glass" window built into the display, claims a Chinese leaker. According to "Smart Pikachu," a Weibo account that has previously shared accurate supply-chain details on Chinese Android hardware, Apple is testing the special glass as a way to let the TrueDepth...
iOS 26

Apple Seeds Second iOS 26.2 Release Candidate to Developers and Public Beta Testers

Monday December 8, 2025 10:18 am PST by
Apple today seeded the second release candidate version of iOS 26.2 to developers and public beta testers, with the software coming one week after Apple seeded the first RC. The release candidate represents the final version iOS 26.2 that will be provided to the public if no further bugs are found. Registered developers and public beta testers can download the betas from the Settings app on...
Google maps feaure

Google Maps Quietly Added This Long-Overdue Feature for Drivers

Wednesday December 10, 2025 2:52 am PST by
Google Maps on iOS quietly gained a new feature recently that automatically recognizes where you've parked your vehicle and saves the location for you. Announced on LinkedIn by Rio Akasaka, Google Maps' senior product manager, the new feature auto-detects your parked location even if you don't use the parking pin function, saves it for up to 48 hours, and then automatically removes it once...
iPhone 17 Pro Cosmic Orange

10 Reasons to Wait for Next Year's iPhone 18 Pro

Monday December 1, 2025 2:40 am PST by
Apple's iPhone development roadmap runs several years into the future and the company is continually working with suppliers on several successive iPhone models at the same time, which is why we often get rumored features months ahead of launch. The iPhone 18 series is no different, and we already have a good idea of what to expect for the iPhone 18 Pro and iPhone 18 Pro Max. One thing worth...
Johny Srouji

Apple Chip Chief Johny Srouji Could Be Next to Go as Exodus Continues

Sunday December 7, 2025 10:41 am PST by
Apple's senior vice president of hardware technologies Johny Srouji could be the next leading executive to leave the company amid an alarming exodus of leading employees, Bloomberg's Mark Gurman reports. Srouji apparently recently told CEO Tim Cook that he is "seriously considering leaving" in the near future. He intends to join another company if he departs. Srouji leads Apple's chip design ...
Johny Srouji

Apple's Chipmaking Chief Johny Srouji Responds to Report About Him Potentially Leaving

Monday December 8, 2025 9:23 am PST by
Apple's chipmaking chief Johny Srouji has reportedly indicated that he plans to continue working for the company for the foreseeable future. "I love my team, and I love my job at Apple, and I don't plan on leaving anytime soon," said Srouji, in a memo obtained by Bloomberg's Mark Gurman. Here is Srouji's full memo, as shared by Bloomberg:I know you've been reading all kind of rumors and...
Intel Inside iPhone Feature

Apple's Return to Intel Rumored to Extend to iPhone

Friday December 5, 2025 10:08 am PST by
Intel is expected to begin supplying some Mac and iPad chips in a few years, and the latest rumor claims the partnership might extend to the iPhone. In a research note with investment firm GF Securities this week, obtained by MacRumors, analyst Jeff Pu said he and his colleagues "now expect" Intel to reach a supply deal with Apple for at least some non-pro iPhone chips starting in 2028....
google pixel 10

Switching Between iPhone and Android Will Get Easier With New Apple and Google Collaboration

Monday December 8, 2025 11:10 am PST by
Apple and Google are teaming up to make it easier for users to switch between iPhone and Android smartphones, according to 9to5Google. There is a new Android Canary build available today that simplifies data transfer between two smartphones, and Apple is going to implement the functionality in an upcoming iOS 26 beta. Apple already has a Move to iOS app for transferring data from an Android...

Top Rated Comments

borneo76 Avatar
150 months ago
iWatch will change the game for wearable device industry :)
Score: 17 Votes (Like | Disagree)
heimo Avatar
150 months ago
No blood alcohol sensor? Not gonna buy it. I want my watch to stop me texting when I'm drunk.
Score: 16 Votes (Like | Disagree)
duky Avatar
150 months ago
Measuring blood glucose, non-invasively? Mm yeah....I'm skeptical
Score: 15 Votes (Like | Disagree)
OllyW Avatar
150 months ago
How would the swear sensor work? What would it be looking for?
Rude words. :p
Score: 14 Votes (Like | Disagree)
Eadfrith Avatar
150 months ago
Health tracking is not the next big thing.

There's a reason why those Fuelbands and Fitbits never caught on.

Tablets never caught on until Apple made one
Smartphones never caught on until Apple made one
MP3 Music Players never caught on until Apple made one.

;)
Score: 10 Votes (Like | Disagree)
mikethebigo Avatar
150 months ago
These leaks don't seem random or accidental. I bet Apple has finalized the design, is good to go with production, and now is starting up the hype machine.

As a medical provider, I'm actually pretty excited about the possibility of blood glucose monitoring. And at least in America, that will certainly get quite a large percentage of the population on board!
Score: 10 Votes (Like | Disagree)