Philips has received 510(k) clearance from the U.S. FDA for its newest ultrasound system, the 5000 Compact Series.
Tag: FDA updates
The U.S. FDA has released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan. This action plan describes a multi-pronged approach to advance the agency’s oversight of AI/ML-based medical software.Read More
“Bioburden reduction systems can play an important role in the ongoing efforts to help address shortages of FFRs,” says FDA’s Binita Ashar, MD.Read More
To ensure medical device cybersecurity safety, the FDA is sharing the discussion paper, Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework, for review and comment.Read More
Commissioner Hahn says the FDA is hiring the best people to analyze healthcare data to make better decisions and adapt as technology changes.Read More
The FDA has issued updated, finalized guidance on a pilot program for laboratories to carry out premarket testing of medical devices.Read More