The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the healthcare industry.

Devices that are approved through a process that does not require any clinical evidence for FDA authorization should not ...

Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be ...

FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for ...

With recent requirements, the FDA is taking a hard stance: cybersecurity is a core consideration with compliance being ...

In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software ...

Gerresheimer AG (GRRMF.PK), a German systems and solutions provider for the pharma, biotech and cosmetic industries, announced Monday ...

SQ Innovation will seek full US approval after the regulatory exclusivity period of a competing product elapses in October ...

Gerresheimer: FDA grants Tentative Approval of SQ Innovation’s Lasix® ONYU* ...

Peter Elkin, chair of the Department of Biomedical Informatics in the Jacobs School of Medicine and Biomedical Sciences at UB ...