In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a ...

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AI-powered medical devices are linked to injuries, recalls, and lawsuits as regulators struggle to oversee a fast-growing wave of artificial intelligence in healthcare.

At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022 ...

IN 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence (AI) to a medical device used to treat chronic sinusitis, an inflammation of the ...

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Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.