“We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”
The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and focuses on information FDA considers necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”
Medtech stakeholders can now search for MedAccred accredited suppliers. Accredited companies included in the QML have achieved MedAccred Accreditation after meeting stringent critical process audit requirements set by MedAccred OEM Subscribers, which include Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics, and Stryker.
Cardio Diagnostics announced issuance of new U.S. Patent for “Compositions and Methods for Detecting Predisposition to Cardiovascular Disease.”
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.
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.
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.
