Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
The Manila Times on MSN3mon
Boost to medical device classification
The task force will help in solving the problems in the approval or registration of stakeholders for medical devices. The FDA will now be able to make the classifications based on the Asean ...
Hosted on MSN7d
FDA alerts users to issue with Olympus’s endoscope component after patient death
Improper or incomplete reprocessing of the MAJ-891 forceps/irrigation plug has led to reports of patient infections.
JD Supra2d
FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
Forbes28d
InnovationRx: FDA Issues New Guidance For AI In Medical Devices
This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices. The memo announcing this change recognizes that the utilization of AI in devices ...
STAT11d
FDA OKs novel device for non-invasive treatment of spinal cord injuries
The FDA Thursday approved the ARC-EX System designed to restore mobility after spinal cord injury by delivering programmed ...
Healthcare Dive28d
FDA issues final guidance on postmarket updates to AI-enabled devices
The Food and Drug Administration issued a much-anticipated update on Tuesday detailing how it plans to regulate changes to artificial intelligence-enabled medical devices after the agency has ...
AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDermCohealyx expected to triple AVITA ...