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

AI-enhanced surgical devices show alarming injury spikes in FDA reports, with navigation systems causing strokes and device ...

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

Central to the Reuters report is the TruDi Navigation System, an image-guided navigation system produced by a Johnson & Johnson offshoot and designed to treat chronic sinusitis. In 2021, the company ...

AI-powered medical devices are linked to injuries, recalls, and lawsuits as regulators struggle to oversee a fast-growing ...

Orthopedics was the most active area over the second half of calendar 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.

Median’s FDA clearance proceeds the FDA clearance of RevealDX’s comparable tool for lung nodule evaluation on 3 February. The ...

Cerebrospinal fluid reportedly leaked from one patient’s nose. In another reported case, a surgeon mistakenly punctured the ...

At least 10 patients were injured between late 2021 and November 2025, according to FDA reports reviewed by Reuters.

The FDA has cleared RevealDx’s AI-powered lung nodule risk assessment software, RevealAI-Lung, according to a company press ...

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