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

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 ...

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 ...

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 ...

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 ...

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 ...