The Sonio Detect fetal image analyzer maker is accused of using a faulty algorithm. Due to this alleged built-in AI error, it purportedly misidentifies fetal structures and body parts, says the report. There have been no reports of patient harm from this analyzer’s use.
Medtronic LINQ implantable cardiac monitors are AI-assisted devices that are alleged to have failed to recognize abnormal rhythms or pauses in patients. Again, no incidents of patient harm are known.
In addition to FDA resources being under strain, as noted previously, the body’s AI device approval screening process may need reworking. Reuters indicates that, currently, the FDA seems to lean a lot on a device’s prior reputation. In effect, they are “positioning new devices as updates on existing ones,” suggests the source. This might help device makers push through their AI-enhanced machines and apparatus quicker, but it doesn’t seem thorough enough when human health is in the balance.
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Mark Tyson is a news editor at Tom's Hardware. He enjoys covering the full breadth of PC tech; from business and semiconductor design to products approaching the edge of reason. ","collapsible":{"enabled":true,"maxHeight":250,"readMoreText":"Read more","readLessText":"Read less"}}), "https://slice.vanilla.futurecdn.net/13-4-13/js/authorBio.js"); } else { console.error('%c FTE ','background: #9306F9; color: #ffffff','no lazy slice hydration function available'); } Mark Tyson Social Links Navigation News Editor Mark Tyson is a news editor at Tom's Hardware. He enjoys covering the full breadth of PC tech; from business and semiconductor design to products approaching the edge of reason.
SomeoneElse23 Someone is seriously brain dead to think AI is accurate enough to assist in surgery. Reply
Notton Reason #1trillion why you don't cut funding to a regulatory organization in charge of food and medical safety in the name of "government efficiency". The only thing underfunding does is increase corruption from bribes and errors from overwork. Reply
SomeoneElse23 Notton said: Reason #1trillion why you don't cut funding to a regulatory organization in charge of food and medical safety in the name of "government efficiency". The only thing underfunding does is increase corruption from bribes and errors from overwork. I'm not sure this would have been stopped by a "fully staffed FDA". It's currently politically correct to find ways to use AI. And I can think of all sorts of things that get approved by the FDA that shouldn't have, because the FDA has been a revolving door from large corporate interests. Reply
alan.campbell99 80% accuracy, sorry but WTF? Reply
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