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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
Yet another headache has arisen for Philips over the recall of its continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices in the form of a class-action lawsuit filed by durable medical equipment (DME) device suppliers. Read More
The medical device industry finds the FDA’s draft guidance on reporting medical device and diagnostic shortages during public health emergencies (PHEs) too far-reaching and too burdensome. Read More
Medtronic was sued Tuesday by the widow of a type 2 diabetes patient who alleges his death was caused by the company’s MiniMed 630G insulin infusion pump. Read More
The FDA has launched an initiative to strengthen the device supply chain against future disruptions like those caused by the current pandemic. Read More