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 Feature

iOS 26.1 to iOS 26.4 Will Add These New Features to Your iPhone

Wednesday October 1, 2025 1:26 pm PDT by
iOS 26 was released last month, but the software train never stops, and iOS 26.1 beta testing is already underway. So far, iOS 26.1 makes both Apple Intelligence and Live Translation on compatible AirPods available in additional languages, and it includes some other minor changes across Apple Music, Calendar, Photos, and Safari. More features and changes will follow in future versions,...
iPhone 17 vs Air and Pros Feature

New iPhones See 'Stronger Than Expected' Demand With One Exception

Thursday October 2, 2025 7:26 am PDT by
Nearly two weeks after the iPhone 17 series launched, analysts at investment banking firm Morgan Stanley said demand for the devices has been "modestly stronger than we originally expected," based on a combination of extended shipping estimates on Apple's online store and information it gathered from Apple's supply chain. There has been strong early demand for the iPhone 17, iPhone 17 Pro,...
macbook air prime day 2025

M5 MacBook Air: Release Date, Features, and Performance Predictions

Friday October 3, 2025 3:39 am PDT by
The MacBook Air is Apple's most popular laptop – a thin, fanless machine that wields quiet power thanks to the efficiency of Apple silicon. While the M4 model isn't exactly old, attention is already turning to its successor. Apple doesn't telegraph new product launches ahead of time, but we can draw a surprisingly clear picture of what to expect by looking at Apple's silicon roadmap,...
iOS 26 Feature

iOS 26 Adds These 200 New Features and Changes to Your iPhone

Saturday October 4, 2025 8:19 am PDT by
Apple's website offers a list of nearly 200 new features and changes (PDF file) included in the software update, released last month. Apple also shared equivalent lists for iPadOS 26 and macOS Tahoe. iOS 26 is compatible with the iPhone 11 and newer. To install the update, open the Settings app on your iPhone, tap on General, and tap on Software Update. Below, we have highlighted eight ...
Tim Cook Rainbow

Apple Event in October? Here's What to Expect

Monday September 29, 2025 9:31 am PDT by
Apple's annual iPhone event is in the rearview mirror, but rumors suggest the company plans to release a handful of additional products before the year ends. Will there be another Apple event this October? We discuss the possibility below. Apple in October Apple's most recent October events were in 2021 and 2023. In 2022 and 2024, Apple did not host an October event. Instead, it...
maxresdefault

The MacRumors Show: Leaks Reveal What Apple Products Are Coming Next

Friday October 3, 2025 8:05 am PDT by
On this episode of The MacRumors Show, we discuss the latest leaks about the next-generation iPad Pro, MacBook Pro, Studio Display, and Vision Pro. Subscribe to The MacRumors Show YouTube channel for more videos Earlier this week, an apparent unboxing video of an updated iPad Pro with the M5 chip was shared online. The same YouTube account leaked the 14-inch MacBook Pro with the M4 chip...
space black mbp

Here's Every New Apple Product That Leaked Yesterday

Wednesday October 1, 2025 8:27 am PDT by
A handful of upcoming Apple products leaked yesterday, through a combination of YouTube videos out of Russia and U.S. Federal Communications Commission (FCC) documents that were released, despite Apple's confidentiality requests. The leaked products include an iPad Pro with an M5 chip, as well as updated MacBook Pro and Apple Vision Pro models. All of these devices had already been rumored...
ipad pro 2024

Next iPad Pro to Have Two Key Features, But One Rumor Still Uncertain

Sunday October 5, 2025 7:00 am PDT by
The next iPad Pro models are rumored to feature two key upgrades, including Apple's M5 chip, and an increased minimum of 12GB of RAM. Last week, apparent unboxing videos for the next-generation 13-inch iPad Pro were uploaded to YouTube by Russian channels Wylsacom and Romancev768. The same YouTube channels leaked the 14-inch MacBook Pro with the M4 chip before it was announced by Apple...

Top Rated Comments

borneo76 Avatar
147 months ago
iWatch will change the game for wearable device industry :)
Score: 17 Votes (Like | Disagree)
heimo Avatar
147 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
147 months ago
Measuring blood glucose, non-invasively? Mm yeah....I'm skeptical
Score: 15 Votes (Like | Disagree)
OllyW Avatar
147 months ago
How would the swear sensor work? What would it be looking for?
Rude words. :p
Score: 14 Votes (Like | Disagree)
Eadfrith Avatar
147 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
147 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)