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The FDA has deemed Smiths Medical’s recall of its Medfusion model 4000 syringe pump as Class I for software issues that can make the pump fail and delay or interrupt therapy or fail to deliver therapy according to the programmed setting. Read More
The list is intended as a tool for hospitals, health systems, ambulatory surgery centers, and manufacturers as a way to identify and mitigate risks. Read More
Despite FDA skepticism, the agency’s Circulatory System Devices Panel advisory committee endorsed Abbott’s TriClip, a transcatheter edge-to-edge repair system intended to treat tricuspid regurgitation. Read More
AdvaMed believes “right to repair” was initiated to focus on cars, cellphones and household appliances, and should not drift into medical equipment regulated by the FDA. Read More
A peer-reviewed analysis of data from a previous study of Masimo’s pulse oximetry device shows accurate measurement of oxygen saturation (SpO2) regardless of skin tones or pulse strength. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Misuse of medical devices at home is the most pressing health technology safety hazard, says one of the nation’s largest nonprofit patient safety organizations. Read More
While consumers wanting the ability to fix products they’ve purchased came through with over 1,600 comments and strongly-worded frustrations supporting their “right to repair” their own possessions, the issue continues to rankle medical device makers looking to protect their intellectual property rights and the safety of FDA-regulated medical devices. Read More
Over the past week, the FDA issued final guidance on reporting drugs and biologicals under Section510(j)(3) of the FD&C Act. Draft guidance was issued on notifications of a discontinuance or interruption in manufacturing under Section 506C of the FD&C Act. The agency also announced meetings of the Oncologic Drugs Advisory Committee and the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. Read More
Consistent open communication and complete public transparency is the only way to counteract scientific misinformation, which is a considerable threat to public health today, said Kimberlee Trzeciak, deputy chairman of FDA’s Office ofPolicy, Legislation, and International Affairs. Read More