Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...

The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger, ...

The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.

Stay ahead of the game with these 5 groundbreaking GI devices featured in Becker's 2024 report, including FDA clearances and innovative partnerships.

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...

Analysis by GlobalData has identified that innovative cardiovascular devices are driving diversification in the growing ...

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...

Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon ge ...

Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that ...

The Food and Drug Administration (FDA) announced that it is studying the expansion of the booklet-free rule for the 20% medicine discount to include persons with disabilities (PWDs), in addition to ...