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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
Bioretec’s bioresorbable implant for pediatric wrist fractures had a significantly lower complication rate than traditional metallic Kirschner-wires (k-wires) and did not require a second surgery, according to research conducted at medical facilities in Hungary. 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 FDA has handed Ray Vision an 11-observation Form 483 after an inspection of the ophthalmic equipment company’s Lake Forest, Calif., facility identified various documentation and other lapses. Read More