There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

MPMN recently spoke with Kevin Fu, software expert and associate professor of computer science at the University of Massachusetts Amherst, about the current risks associated with medical device ...

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the ...

New Delhi: After the Union Ministry of Health notified the draft amendment to the Medical Devices Rules, 2017 on 10 April, India’s medical device industry has pushed back against two proposed ...

The 2023 State of Cybersecurity for Medical Devices and Healthcare Systems report, a collaboration of the Health Information Sharing and Analysis Center with Securin and Finite State, examined the ...

The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical ...

Software as a Medical Device, Second Edition is your new guide to one of healthcare’s fastest-evolving frontiers: the intersection of software, regulation, and artificial intelligence. This book ...

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...