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HeartBeam Stock Slumps After FDA Refuses Clearance For ECG Software

Roth Capital sees potential FDA clearance for the software. ・The FDA may want the company to use a different predicate device ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
Law

AI in Software as Medical Devices (SaMD): Navigating Patent and Regulatory Challenges in the US, Europe

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
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FDA seeks industry feedback on AI medical device safety monitoring

The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...
JD Supra

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System ...
Medical Device and Diagnostic Industry (MD+DI)

Software Version Control for Medical Devices: Turning Traceability into Compliance Confidence

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
STAT

Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients

Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of pandemic burnout. But when longtime medical device director Jeff Shuren announced his departure in July ...