A review paper from the Agency for Healthcare Research and Quality supports the benefits of computerized clinical decision support systems (CDSS) in reducing medication errors and adverse drug events, but also uncovered risks and unintended consequences that must be addressed to improve patient safety and implementation of next generation systems.
LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).
The National Institute of Standards and Technology (NIST) has developed a system that mimics humanlike models for studying cardiovascular disease to reduce the reliance on animal testing and shorten drug development timelines.
The 25th session of the International Medical Device Regulators Forum will be held March 11-15 in Washington, DC. The free event is open to the public and includes both in-person and virtual attendance options, Registration deadline is February 16.
A new survey from Frost & Sullivan highlights the key barriers to adoption of real world data and analytics in health care and life sciences.
Vladimir A. Makatsaria, who most recently served as Company Group Chairman at Johnson & Johnson MedTech, leading its global Ethicon surgery business, has been appointed CEO of global medical technology company LivaNova. Former CEO Bill Kozy will serve a Board Chair.
Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.
As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).
The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.
If adopted, companies would have additional time—from 2027 to 2029, depending on the type of device—to gain approval under EU IVDR.
