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 ...

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

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 ...

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 ...

SubtleHD(CT) joins Subtle’s other AI medical imaging products including SubtlePET and SubtleHD(MR) that aim to improve PET ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

The International Medical Device Regulators Forum, a medical device-focused regulators-only successor group to the Global Harmonization Task Force (GHTF), has released a new document for consultation ...

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 and ...

For SLAS US 2023, we speak to Guy Starbuck, one of the co-founders at AIQ Global, about how we can utilize AI technology to bring new medical devices to market. Please could you introduce yourself and ...

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 ...

Because it is getting harder to underestimate "the evil genius of the modern-day cybercriminal," Eracent, which develops asset management tools for software and IT, says it will offer healthcare ...

Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...