A new survey from the Center for Connected Medicine at UPMC Sheds light on how healthcare systems are navigating both the promise and the possible risk of AI and generative AI.
Leading hospital systems are advocating for “immediate transition” to digital communication to manage supply chain disruptions and enhance patient safety.
Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.
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.
