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

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 ...

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

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

Integrating a controlled-release iodine layer into hip implants could reduce the rate of potentially fatal infections.

Sirona Medical today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking a significant regulatory milestone and the ...

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 ...

FDA says Philips devices from U.S. plants were adulterated due to poor manufacturing and oversight, adding to the company's ...

The partnership seeks to address the increasing regulatory and operational demands for robust, life-cycle-spanning medical ...

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