FDA said today that it set a record for novel-device approvals in 2018, giving the nod to 106 new devices, breaking the previous record of 99. The agency also granted nine breakthrough device designation requests, for a total of 112 since the program’s inception in 2015. Novel-device approvals in 2018 included an expanded approval of an […]
Banyan Biomarkers
Banyan Biomarkers wins 1st FDA nod for concussion blood test
Banyan Biomarkers this week won FDA clearance for its Banyan Brain Trauma Indicator blood test designed to evaluate concussions in adults, making it the first such test of its kind to get a pass from the federal watchdog. Approval for the device came through the the FDA’s breakthrough devices program and took only six months […]
FDA announces traumatic brain injury biomarker workshop
The FDA today announced plans for a workshop to discuss the development of technologies for detecting biomarkers related to traumatic brain injuries. The aim of the workshop is to discuss both the challenges and solutions related to biomarker development methodologies, the FDA said. During the meeting, the agency will seek to establish strategies for standardizing […]
Philips and Banyan ink deal to dev handheld concussion test
Royal Philips (NYSE:PHG) and blood test developer Banyan Biomarkers said today they inked a deal to develop and commercialize a handheld blood test to test for concussions. Financial terms of the agreement were not disclosed. The new test will be based on Philips’ Minicare I-20 system, and will useable at the point of care, the […]