Apple Watch faces potential import ban in the US | The International Trade Commission has found Apple in violation of a bloody oxygen tracking patent owned by Masimo.
Apple could be potentially facing an Apple Watch import ban in the US for infringing a blood oxygen tracking patent owned by Masimo.
Apple Watch faces potential import ban in the US | The International Trade Commission has found Apple in violation of a bloody oxygen tracking patent owned by Masimo.::Apple could be potentially facing an Apple Watch import ban in the US for infringing a blood oxygen tracking patent owned by Masimo.
Medical patents and approvals are an interesting miasma of red tape. Apparently the new Pixel 8's have been having some hurdles with them. They contain a temperature sensor which can supposedly be used to check body temperature and monitor for disease. But merely checking body temperature makes it a Class II medical device which requires a ton of paperwork and red tape from the FDA, with disease tracking making it even more difficult. So that's why the Pixel 8 was released with a temperature sensor which, for now, can only be used to measure external things and is prohibited from being accesed by third part developers.
Another good example is 23andme. When they first started, it wasn't just genealogy information. They'd give a whole background of genetic diseases and conditions you might be at risk for. Then the FDA found out and shut it down since they didn't go through the hoops required to give out medical advice. So even though they have the complete capability to gather that information accurately, they are no longer allowed to provide it to their customers, simply due to red tape.
No, they aren't allowed to do genetic testing for actual genetic diseases, like the mutation in this gene causes Huntington's Disease or something. They are allowed to comment on vague things like genetic modifiers of common diseases (like, people with this change have a relative risk of heart disease is 2.5% higher than the population).
They also don't have the capability to do that genetic testing for actual diseases safely or accurately. Or else they would have no problems complying with fda regulations that are in place for medical tests for good reason. There's tons of companies that do genetic testing, even whole exome and whole genome, it's easier than ever to get genetic testing done relatively cheaply. Those companies also have to do things like provide access to genetic counselors and followup family testing. 23andme doesn't want to do any of this stuff, they just wanted to charge you cash directly and plop a bunch of information directly in front of someone that's tough even for doctors and genetic counselors to interpret, and all the many many problems that would have led to.