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The U.S. International Trade Commission (ITC) has affirmed its June initial decision and has once again sided with AliveCor that Apple infringed on AliveCor’s wearable electrocardiogram (ECG) device patents, potentially halting importation of certain Apple watches.
President Biden signed into law a $1.7 trillion omnibus spending package on Dec. 23, appropriating $3.5 billion in discretionary funding for the FDA through Sept. 30, 2023 — an increase of $226 million, or 6.5 percent, from what was enacted for the agency in 2022. Read More
The FDA has identified Arrow International’s Oct. 17 recall of its intra-aortic balloon pumps as Class 1 because the device’s short battery life may cause serious injury or death. Read More
Philips said Wednesday that independent testing on its recalled DreamStation devices showed that exposure from degraded sound abatement foam on the devices is unlikely to result in “appreciable harm” to patient health. Read More
The FDA has drawn mixed reactions to its draft guidance on reducing healthcare disparities in its Breakthrough Devices program, including support for creating greater flexibility for entry into the program, but also concerns about approvals that might lack sufficient evidence and ultimately jeopardize patient safety. Read More
The EU’s Medical Device Coordination Group (MDCG) has released new guidance and templates to help devicemakers in filing the newly-required Periodic Safety Update Reports (PSURs) based on postmarket surveillance. Read More
AdvaMed has filed an amicus brief with the U.S. Supreme Court seeking reversal of a California appeals court’s $300 million ruling against medical device maker Ethicon, arguing that the court applied the state’s consumer protection laws too broadly. Read More