USPTO Issues Patent for Risk Detection of Cardiovascular Disease
Cardio Diagnostics announced issuance of new U.S. Patent for “Compositions and Methods for Detecting Predisposition to Cardiovascular Disease.”
Application Period Open for Excellence in Pursuit of Health Equity Award
The Joint Commission and Kaiser Permanente are accepting applications now through April 30 for the 2024 Bernard J. Tyson National Award for Excellence in Pursuit of Healthcare Equity. The award recognizes major achievements in improving healthcare disparities.
NIST Releases Updated Cybersecurity Framework
The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types. This is the framework’s first major update since its creation in 2014.
AI Oversight of Growing Interest to Health Care Executives
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.
Healthcare Providers Call for Universal Platform for Recalls and Other Supply Disruption Alerts
Leading hospital systems are advocating for “immediate transition” to digital communication to manage supply chain disruptions and enhance patient safety.
FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data
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.
Benefits and Risks of CDSS To Prevent Medication Errors and Adverse Drug Events
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.
MHRA Announces New UK Approved Bodies
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).
NIST Introduces Heart-on-a-Chip for Cardiovascular Research
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.
Registration Opens for March IMDRF Meeting in Washington, DC
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.
