Shares in nuclear medicine play Clarity Pharmaceuticals have surged up to 12% after the company's swift and supersized $203 ...

Over the past decade, health insurance companies have increasingly embraced the use of artificial intelligence algorithms – ...

The introduction of the Person Responsible for Regulatory Compliance (PRRC) role mandated under the Medical Device Regulation (MDR) 2017/745 and the In-vitro Diagnostic Device Regulation (IVDR ...

The FDA granted Breakthrough Device Designation for AVIM therapy, targeting over 7.7 million patients with uncontrolled hypertension.

The FDA’s partnership with the Digital Health Center of Excellence is exploring how to adapt software-as-a-medical-device (SaMD) frameworks to AI-enabled products.

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent ...

Medical device regulation: Current challenges Before reaching the market, all medical devices are required to meet stringent efficacy and safety standards.

A lawyer specializing in FDA regulation, who spoke on condition of anonymity, said her clients at large medical device companies were deeply concerned that the FDA would start missing deadlines ...

Merit Medical announces FDA approval for WRAPSODY device, enhancing dialysis patient care by improving long-term vascular access.