The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under ...

The court’s rationale Opposition against the IIa classification of telemedicine software Is telemedicine software a medical device at all? Impact on practice and the market Telemedicine is getting ...

MOUNTAIN VIEW, Calif., Nov. 19, 2019 /PRNewswire/ -- Respond Software, innovator in Robotic Decision Automation (RDA) for security operations, announced today the launch of its First Responder Service ...

Medical apps, treatment planning software, and even firmware for ultrasound devices: software is legally classified as a medical device if it is used for medical purposes. This includes diagnosing, ...

BRUSSELS – The European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device ...

The main market opportunities lie in mastering regulatory decisions for software innovations in healthcare, particularly for digital therapeutics and AI. Navigating complex global regulations ...

LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 22, 2026 / ClearPoint Neuro, Inc. (CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to ...