Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. MINERVA, Ohio (WJW) – A local company has ...

The ANSI-ASQ National Accreditation Board (ANAB) recently notified the US Food and Drug Administration that LSQA SA of Montevideo, Uruguay now is accredited as a certification body (CB) by ANAB under ...

Three Democratic senators are requesting additional information about the FDA’s Pre-Cert for Software Pilot Program, a streamlined regulatory pathway for digital health technologies that the agency ...

The Apple Watch series AFib feature has received new approval from the FDA. From now on, the results returned by the devices are considered medical grade. Previously, the results could be considered ...

WASHINGTON — Drug testing facilities that have invested in oral-fluid-based testing for motor carriers, airlines, railroads and pipeline operators are pushing back on a proposal by the U.S. Department ...

Dr. Harvey Karp nearly announced last summer that the FDA certified that Snoo reduces SIDS. But FDA approval of the $1,700 high-tech crib never came — and month's later is still missing. Experts say ...

AGC Biologics announced that its Seattle manufacturing facility achieved operational excellence milestones in 2025.