The emergence of artificial intelligence has made a huge impact on industries around the world and healthcare has been ...

XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...

The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based ...

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...

As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.

Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...

To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations, and clinical trial regulations.

"Receiving this approval marks a significant milestone for Paragonix and Getinge, reinforcing our commitment to delivering innovative and regulatory-compliant medical devices,” said Dr. Lisa ...

More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...