The global disposable medical device market is set to expand from USD 113.95 billion in 2025 to USD 144.85 billion by 2030, ...

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...

The FDA’s regulations and expectations for medical devices are designed to ensure that benefits outweigh the risks. In three months, the U.S.

It was the latest shockwave to sweep through an agency beset by all kinds of tumult in recent months. In interviews, ...

Vivos Inc. (OTCQB: RDGL) announced today that they have appointed Dr. John J. Smith, M.D., J.D., and his team at Hogan ...

The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.

The U.S. Food and Drug Administration has flagged three of Philips' medical device facilities after inspections found they ...

The collaboration will facilitate the provision of secure over-the-air software updates for connected devices.

Thirdwayv and Medcrypt are partnering to provide integrated cybersecurity solutions for connected medical devices throughout ...

George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory ...

At The Constellation Forum 2025 in New York, Gottlieb said there are and will continue to be challenges regulating software ...