Posted on 04/26/2020 4:43:57 PM PDT by absalom01
Millions of Americans own an Apple Watch, which commands roughly a 50 percent share of the smartwatch market. Among its many features, the Apple Watch can take your pulse. It also contains hardware to measure your blood-oxygen levels, and it has been doing so since the watch was released—but the hardware is not operable by the watch’s wearer, who thus cannot obtain the results. Under current FDA regulation, the function is disabled. It’s another example of how federal regulation of the production and distribution of pharmaceuticals and medical devices in the United States is less focused on stopping viruses and other diseases than on blocking private-sector innovators from developing solutions that may not work or might have harmful side effects.
This matters in the Covid pandemic. On April 20, emergency-room doctor Richard Levitan described in the New York Times what he’d observed treating patients in Bellevue Hospital in New York. Levitan had seen many cases of “silent hypoxia,” unknown oxygen deprivation in which “patients without respiratory complaints had Covid pneumonia”—even those admitted to the hospital for non-Covid-related health concerns. By the time most patients made it to the hospital, they had “remarkably low oxygen saturations.” Levitan’s recommendation: “Widespread pulse oximetry screening [as] an early warning system.”
...
The FDA’s reluctance to cede control is understandable. The agency always faces harsh public and congressional scrutiny over drugs and devices that fail or cause harm. No one wants to see the next Theranos. But delay in introducing devices tied to human health also costs lives—even in ordinary circumstances, and especially in a pandemic. The FDA’s misplaced focus on perfection over speed tragically bottlenecked U.S. testing for Covid-19. Even the availability of something as basic as ethyl-alcohol hand sanitizer has been stalled by FDA oversight.
(Excerpt) Read more at city-journal.org ...
I don't know what one citizen can do...write my congresscritter maybe. "Dear Adam Schiff...", no, that won't work. At the very least, I'll be doing everything that I can think of the help Trump get re-elected so he can turn his attention to really cleaning house in the executive branch.
The suffocating regulations of the FDA and other agencies is a big reason China rose to power.
But yet you can buy this little device you stick on the end of your finger like at Walmart for around $50 that does the same thing.
“Trust the experts” proclaimed, and still do, the Corona hysterical Freepers.
I bought a pulse oximeter at CVS for $15. Bit I cannot activate the feature on my iPhone. Genesis.
Genius
You could send Schiff a beautiful big powerful letter, you know,something really huge.
In thy future, the outside of the watch frame will have test strips and topi can poke your finger and put the slip into the watch and read for STDS and HIV.
Great post. Here’s another example. Over a year ago, Withings introduced the relatively inexpensive Move ECG watch at the Consumer Electronics show. About half a year ago, it was approved for use in Europe by the comparable body there. The FDA, the last I knew, had still not approved it.
New firms, operating on tight budgets, might just as well forget introducing devices needing FDA approval.
I bought mine for $35, I think. Last year. Th local pharmacies were a little more expensive, from $45-60.
My Garmin Fenix5X has been monitoring my pulse ox levels for 2 years at least.
Unelected bureaucracy is creeping Socialism. It is based on Central Planning which is the corner stone in the foundation of all tyranny.
We have been shown by the severe mishandling of this Pandemic that we must clean house, or there will be no room for us in it anymore.
I use my Samsung phone’s sensor to get O2 levels all the time
Yeah, somewhere around that price - but WTH is it with the FDA?
The most important and expensive part of FDA approval is the Bribery. I know a pride winning Organic Chemest that spent his life savings to get an extract from the kernel of almonds that cleared up prostate cancer approved that finally gave up after 3 years and all his and his partners money ran out.
Nothing makes a bean counter move slower than Power.
After what just happened with Russia and the ukrianiam bs , how could anyone not have known the corona virus was a hoax? Cuomo sent elderly who were still testing positive with corona virus. He killed so many seniors at nursing homes. They had to make sure they exposed the weak to get the hysteria going.
$15? I’ve never seen them lower than $50 at cvs.
When I bought one for my mom 3 years ago, they were $70
Bingo. So evil.
Well, not today you can’t.
People got the word, and the shelves cleared out.
What got under my skin with this story was that Apple has the hardware, right now, in millions of units, and could turn it on tomorrow with a software patch. Now, maybe there could be some question for Apple, as this has been out for years, and they didn’t bother with the FDA application, for whatever reason.
The FDA is these cases is actually making things worse with their over-regulation.
Yes I know. Can’t even find thermometers either.
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