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FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews.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, ...
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.
George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory ...
FDA says Philips devices from U.S. plants were adulterated due to poor manufacturing and oversight, adding to the company's ...
Anteris Technologies has won FDA approval to conduct a key clinical trial for its heart valve device in the US.
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