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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
The Basis Health 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 Roundups: Apple Watch, watchOS 5, watchOS 6
Buyer's Guide: Apple Watch (Caution)

Top Rated Comments

(View all)

67 months ago
iWatch will change the game for wearable device industry :)
Rating: 17 Votes
67 months ago
No blood alcohol sensor? Not gonna buy it. I want my watch to stop me texting when I'm drunk.
Rating: 16 Votes
67 months ago
Measuring blood glucose, non-invasively? Mm yeah....I'm skeptical
Rating: 15 Votes
67 months ago

How would the swear sensor work? What would it be looking for?

Rude words. :p
Rating: 14 Votes
67 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!
Rating: 10 Votes
67 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.

Rating: 10 Votes
67 months ago
I just hope health book can figure out when I am going to die so I know when to party it up.

ETA till death: 1 year, 2 days remaining...

Imagine siri giving you the update: "you went for a walk today, and only had 2 vodkas last night, you have added another week to your life."
Rating: 8 Votes
67 months ago

Health tracking is not the next big thing.

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

If they truly had a way to give non-invasive glucose readings, that'd be a big thing: Lots of people have an increased risk of developing diabetes due to lifestyle and/or family history. There's definitely a market for something that could conveniently and reliably(!) alert you to the early warning signs.

Then again, most people commenting on this seem to agree that there's currently no technology for measuring glucose levels in that way, so I'n not holding my breath for that one.
Rating: 7 Votes
67 months ago

Health tracking is not the next big thing.

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

You have absolutely no clue what you are talking about.

If this rumour is indeed true and Apple has a glucose meter functionality in its iWatch then this will be a game changer that will rival the iPad.

Why is this? There are millions of Diabetes 1 and 2 persons reliant on glucose meters. The test strips for those alone generate a yearly global revenue of 10 Billion for that entire market combined. Considering the lack of convenience with test strips (ask any diabetes patient) they will gladly switch to a non-invasive version and pay premium amounts for it.

If indeed true, than Abbott Diabetes Care, Lifescan, Bayer and Roche have a serious problem.

And that is only the glucose part. If the other sensors are also FDA approved, then this watch will replace a whole host of different sensors that people use both from a personal fitness but also health perspective (as in prescribed blood pressure monitors etc).

I work for a technology consulting company that works in wearables, health monitoring and other medical applications. We see our market growing explosively and very rapidly expanding into consumer territory.

Fitbits and Fuelbands are only the tip of the iceberg here. Accurate (hence FDA approval) Health Tracking and data management is the next frontier. You personally might not be interested in it, but it is the case.

p.s. the global amount of people with diabetes increases with 2.3% each year. Mostly in China, Middle East and the USA. This is a fast growing market with the need for a consumer ready replacement for the test strip model.
Rating: 7 Votes
67 months ago
I don't use watches cause i feel them uncomfortable,so it will be very difficult that Apple convince me to wear one.
Rating: 6 Votes

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