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Concerns about unexpected shutdown leading to possible injury and/or death has caused the FDA to issue an alert about several cardiac devices manufactured by Getinge/Datascope/Maquet. Read More
A mobile app that controls an insulin pump has been recalled for a software problem that potentially leads to crash of the app and pump battery depletion. Read More
Clarity on the definition of “remanufacturing” for reusable medical devices needing maintenance or repair is the focus of a final guidance the FDA issued on Thursday. Read More
The FDA and NIH are asking stakeholders for support in developing a glossary of terms related to clinical trial innovation especially for terms involving real world data (RWD) and real world evidence (RWE). Read More
A major agency-wide reorganization affecting regulatory affairs and medical products, and more than $12 million to tackle supply chain issues across all products areas, were included in the FDA’s FY 2025 budget proposed to a Senate Appropriations subcommittee Wednesday morning by Commissioner Robert Califf. Read More
The United Kingdom’s medicines and medical devices regulator has unveiled its approach to AI in a report presented to the UK government, urging transparency, inclusivity and aligning with partners globally among its key published principles. Read More
Five EU regulatory authorities have published a joint plan to support the implementation of the One Health agenda in the EU, a plan help prevent and respond to health threats. Read More
HHS leadership and coordination challenges with handling public health emergencies, particularly its management of the Strategic National Stockpile (SNS), was scrutinized in a Government Accountability Office (GAO) report resulting in recommendations for improvement. Read More
This edition of Quick Notes reviews the FDA’s 510(k) clearance of a ZygoFix spinal fusion device, GE Healthcare’s vital signs monitor, an EEG monitoring system and AI for event detection by Epitel, and BMF cosmetic dental veneers. Read More