sandor
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Apple's non-invasive glucose reader for Apple Watch may be 'years away'
lkalliance said:Why would a non-invasive (and from the little biology I know, I don't see how it could be) device require FDA approval, especially over the next few years as the current administration attempts to deregulate everything. How would it be any different than a blood pressure gauge? I don't think my gauge is FDA approved. And unless there's a way to measure blood glucose via saliva, I don't see how it could ever be non-invasive anyway. Of course there probably would be a way for a device to track the results from urine test strips, but it's the strip that's already doing all the work. Unless they expect us to urinate on our phones or watches.It has to do with indications for use. Although a patient might use a reading from a blood pressure monitor to make personal healthcare decisions, he would more likely take that data to his doctor, I would think. A diabetic makes immediate decisions based on the readings from his meter.
From what I understand, potential non-invasive glucose measurement involves shining light through the skin and watching how that light gets diffracted. Therein lies a big challenge: glucose molecules are very basic things, and light reflected off one doesn't have a distinctive look to it. It could have bounced off of anything, not just glucose. Perhaps they find a way to measure some secondary substance. I don't know if it's still the case, but Continuous Glucose Monitors don't test your blood but rather the interstitial fluid between cells, which has a strong correlation. Strong, but not strong enough to use the data for insulin dosing: you need to actually test your blood for that. A non-invasive CGM would be really good...a non-invasive blood tester that I could use to set a dosage would be AWESOME.
This has led to a shrinking of the medical devices both in size & price thus leading to a greater number of applicable scenarios including oxy/de-oxy blood levels, glucose & material differentiation.
https://www.ncbi.nlm.nih.gov/pubmed/?term=near-infrared+spectroscopy
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Apple's non-invasive glucose reader for Apple Watch may be 'years away'
zoetmb said:sandor said:macxpress said:
I have had to write IRB protocols for non-approved devices & we have been a clinical site for FDA data gathering pre-approval as well.
we can wait 12-18 months for software algorithms to make their way through the FDA, hardware can be years in the testing & approval phases.
I didn't know until now that Jobs also had diabetes. It certainly wasn't a weight issue and from what we supposedly know about Jobs, he probably didn't eat processed foods with high sugar and fat content, although I think there was some anecdote about him demanding an ice-cream soda in a restaurant that didn't ordinarily serve them.
actually, like all devices - but especially rampant in the low cost, high consumer sales areas, there are non-FDA or CE cleared blood pressure cuffs & FDA & CE cleared ones.
http://www.clinical-innovation.com/topics/practice-management/fda-grants-510k-clearance-caretaker-medical’s-blood-pressure-and-heart-rate-monitor
https://www.accessdata.fda.gov/cdrh_docs/pdf8/K080319.pdf
https://510k.directory/clearances/K970139
http://www.caretakermedical.net/fda-approves-caretaker-wireless-remote-patient-monitor-for-continuous-non-invasive-blood-pressure-cnibp-and-heart-rate-monitoring-using-patented-finger-cuff-technology/
https://www.businesswire.com/news/home/20160217005577/en/Masimo-Announces-FDA-510-Clearance-Root®-Noninvasive
http://www.massdevice.com/iphone-and-ipad-blood-pressure-app-wins-fda-clearance-massdevice-medtech-monday/
just because there are non-510k cleared devices doesnt mean that they *shouldn't* be 510k cleared.
and non-invasive devices are even more highly tested, and rightfully so, as they need to be proven effective, accurate & non-harmful on the general population.
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Apple's non-invasive glucose reader for Apple Watch may be 'years away'
macxpress said:
I have had to write IRB protocols for non-approved devices & we have been a clinical site for FDA data gathering pre-approval as well.
we can wait 12-18 months for software algorithms to make their way through the FDA, hardware can be years in the testing & approval phases.
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Apple's non-invasive glucose reader for Apple Watch may be 'years away'
NY1822 said:I'll place my bets on Apple vs "Industry Experts"...
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Apple's 'iPhone SE 2' rumored to ship in first half of 2018, made in India
adm1 said:Wish everyone would stop calling it the budget iPhone. For most of us, it's the size that counts, not the cost - if it were specced and priced the same as the iPhone 8, similar to what Sony did with they're Z range, I'm sure it would still sell in the millions.
Battery upgrade is a welcome boost, I've been impressed by my wife's iPhone 8 battery life so if it's at least on par with that I'd be delighted.
it does absolutely everything i need it to do & it fits in my pocket (mostly)
i have no need & no desire for a giant screen on my phone.