Modern medicine helps us stay healthy and recover from illnesses that once had no cure. But getting here took centuries of ...

The FDA issued four medical device recalls involving syringes, ventilator circuits, and catheters due to risks of injury and device failure.

An analysis of AI-powered devices that received FDA's "breakthrough" label shows a preference for big-picture, multi-problem ...

Opportunities exist in developing new sterile medical devices, improving sterilization processes, and ensuring compliance with evolving regulations and standards. There's potential in providing ...

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...

Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration, announced to staff on Tuesday that he is leaving the agency, according to six sources and an email ...

Abbott also reported compensation increases for its CEO and other executives, plus a big jump in its median employee pay.

The idea of a medical device that is fully recyclable or completely biodegradable appeals to many in the industry – even patients. Although progress has been slow, the medical device industry is ...

Market opportunities include enhancing medical device quality through robust process validation training, aligning with regulatory and QMS needs, and integrating GAMPv for improved data integrity.