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The FDA is making significant organizational changes to the Center for Devices and Radiological Health (CDRH), which plays a lead role within the agency in how medical devices are evaluated or cleared for clinical investigations and marketing. Read More
Distinguishing between devices and drugs for regulatory purposes can be difficult in some cases, but the European Commission’s Medical Device Coordination Group (MDCG) has released a new guidance document that aims to help. Read More
Three device manufacturers reported positive study results for their products at the International Conference on Advanced Technologies and Treatments for Diabetes taking place this week in Barcelona, Spain. Read More
The FDA issued an advisory yesterday about potential airway obstruction and ventilation failure from the use of Medtronic’s silicone-based electromyogram (EMG) endotracheal tubes. Read More
In remarks yesterday before a Senate subcommittee to discuss the FDA’s fiscal 2023 budget request, FDA Commissioner Robert Califf focused on hoped-for initiatives to shore up cybersecurity and the supply chain for devices, and touched on what may become of Emergency Use Authorizations (EUAs) for devices after the public health emergency is declared over. Read More
Physician-inventors who own device companies have some relief from worrying about violating the federal Anti-Kickback Statute (AKS), thanks to a favorable advisory opinion from the Department of Health and Human Services (HHS). Read More
Blackrock Neurotech has purchased the Bethesda, Md.-based software firm MindX for an undisclosed sum, acquiring the company’s brain-computer interface technology. Read More
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), apologized yesterday to the Senate Committee on Health, Education, Labor and Pensions (HELP) for missing the deadline to send the final Medical Device User Fee Amendments (MDUFA) V commitment letter to Congress by the Jan. 15 deadline. Read More
Philips Respironics has received a subpoena from the Department of Justice (DOJ) for documents relating to its recalls of millions of continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices. Read More
Qvella’s Field Activated Sample Treatment (FAST) system recorded similar results to other blood culture diagnostic tests but delivered the results 24 hours sooner, according to a study by researchers in Germany. Read More