The Medicines and Healthcare products Regulatory Agency (MHRA) is stepping up its collaboration with the U.S. Food and Drug Administration…
Browsing: Regulatory
Today the U.S. Food and Drug Administration (FDA) is announcing a new Innovation Challenge titled, “READI-Home: Reducing Readmissions through Device…
The American College of Radiology (ACR) has announced its ACRedit Plus and National Radiology Data Registry (NRDR®) platforms have earned certified status by HITRUST for information security.
The FDA’s Center for Devices and Radiological Health’s (CDRH) mission is to protect and promote public health while supporting timely access to innovative, safe and effective medical devices and safe radiation-emitting products.
Aligning the lists will streamline safety event reporting and ultimately reduce reporting burden for clinicians, hospitals, and health systems.Â
The FDA is aware that aware that Siemens Healthineers sent all affected customers an Urgent Medical Device Correction letter for 3 Tesla Siemens Healthineers MRI systems due to the potential for an ice blockage to form or currently exist within the magnet venting system.
AdvaMed, the medtech association, has submitted formal comments responding to the U.S. Department of Commerce investigation into whether the U.S.’s current level of medtech imports has national security implications.
The AHA highlighted how many pharmaceutical products are imported and that many medical devices are manufactured overseas.
A Class I recall has been issued by Siemens Healthineers for several of its 3T MR and PET/MR scanners because of a potentially serious safety issue with the magnet venting system.
The U.S. Food and Drug Administration (FDA) announces a “Request For Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device…
