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The proposed European Artificial Intelligence Act (AIA) will impose an additional burden on the already limited number of notified bodies, resulting in delays in the marketing of new medical devices and technologies, the European Association of Medical Devices Notified Bodies (Team-NB) says.
Advanced Bionics has agreed to pay more than $12 million to resolve allegations that it made false claims in premarket approval applications (PMAs) for some of its cochlear implant processors, the Department of Justice said.
Philips is temporarily pausing reworking its recalled Respironics Trilogy 100 and Trilogy 200 ventilators after two new issues have been found with breakdown in the devices’ sound abatement foam.
BioTelemetry and its subsidiary CardioNet — both owned by Philips — have reached a $44.8 million agreement with the Department of Justice (DOJ) to resolve False Claims Act allegations that the companies billed the federal government for test analysis performed outside the U.S.
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