Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics.

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade ...

The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among ...

The reduction in force at the FDA could worsen security and patient safety, witnesses said. Kevin Fu, who served as acting director of medical device security at the FDA’s Center for Devices and ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

Zeiss Medical Technology announced today that it received FDA 510(k) clearance for the Intrabeam 700 platform.

Interview with Joe Silvia, CEO of MedWare Cyber Click here to listen. In late January, the FDA issued a safety warning on Contec CMS8000 patient monitors and those relabeled as MN-120. The ...

There are a broad range of medical devices that may be vulnerable to cybersecurity breaches, said Rep. Gary Palmer (R-Ala.), chairman of the House Energy & Commerce Oversight and Investigations ...

I3CGlobal The core concept of FDA 510k software medical device clearances I3CGLOBAL is a trusted regulatory consulting firm spe ...

San Clemente, California Wednesday, April 9, 2025, 11:00 Hrs [IST] ...

With these FDA clearances, ICU Medical is introducing its new category ... anywhere, to help ensure devices are consistently updated and pumps are on the most current software version. Full IV-EHR ...