I would buy it, if it’s accurate.
Me, too. My A1c is well below “medical need to monitor regularly”, but it’s been creeping up, and if i could get useful feedback on what affects my blood sugar, to help me keep it in the “it’s fine” range, it would be worth dealing with a watch that isn’t the watch i want in a lot of ways.
I agree.
There’s accurate enough for a fitness app and accurate enough for a medical device.
An article discussing the criteria regarding “wellness” apps and software, and medical devices and accessories (the latter of which has an appropriately high regulatory burden).
Continuous monitoring without needing to poke holes in my skin would be more valuable to me than precision. And even if it occasionally hiccoughed and gave weird inaccurate results, if it was mostly accurate, i think it would be useful.
So i guess I’m saying that a fitness app would likely have a huge market.
Not disagreeing, although the issue between the wellness device and the medical device line is not the occasional obviously off numbers. It’s a level of proof and standard of what counts as “mostly accurate.”
I have no doubt that “the worried well” is a huge market.
Let’s hope they don’t make it a medical device. If they do, it will take ten more years to get to market and cost $5,000.
So true. And this can result in the delivery of so much unnecessary care. But that’s a whole 'nuther thread.
Done.
Never been above 6.3, but a combination of Metformin (500 mg) and a low-total-carb diet (that’s Total carbs, not just Net carbs; I called it the What’s That Diet - Bread? Pizza? Pasta? Rice? Beans? Most fruit? Pancakes? Dessert? What’s That?) dropped it down to 5.7 - and I lost about 50 pounds and 15 points off my blood pressure as a result as well.
The Apple Watch already is a medical device:
They couldn’t claim to detect Atrial Fibrillation without the approval. The functionality was disabled in Canada until HC gave the go ahead.
Link from Apple:
That’s great, especially since I’m Canadian… But US FDA approval can take an inordinately long time and a huge expense for medical device approvals.
To be fair, this really applies to startups, where the cost of FDA approval can be 3-4 times the cost of making the device itself. But the overall cost is not that high for a company like Apple - $30 million or so on average.
A good summary of regulatory costs for medical devices: