While enterprises continue to respond to the end of life of Windows 10 and the wide scale adoption of Windows 11, there are ...
The FDA’s regulations and expectations for medical devices are designed to ensure that benefits outweigh the risks. In three months, the U.S.
ProMed, a recognized leader in precision manufacturing for regulated industries, continues to set benchmarks in the application of silicone over molding for medical devices.
The US Food and Drug Administration (FDA) has hit Philips with a warning letter after quality control shortcomings were uncovered at three of its medical device manufacturing sites.
The U.S. Food and Drug Administration has flagged three of Philips' medical device facilities after inspections found they ...
Investing.com -- Koninklijke Philips N.V. (NYSE:PHG) stock fell 8% after the U.S. Food and Drug Administration (FDA) issued a warning letter to the company regarding multiple violations found during ...
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The acquisition joins the local ...
The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real ...
Today's pacemakers are about the size of a small matchbox, and future models are expected to shrink even further, becoming smaller than a grain of rice. Now, these devices, depending on the model, can ...
Nisha Gopalan is a former Senior Overnight Assignment Editor for Investopedia News. She is an award-winning financial journalist who has worked in London, where she is currently based, and Hong Kong.
FDA clearance is a vital milestone for ASX medical device companies, opening access to the US market while navigating the regulatory process.
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...