BrainScope announced that it launched its third FDA-cleared algorithm for concussion diagnosis on the BrainScope device. Bethesda, Md.–based BrainScope’s Concussion Index is the first physiological marker of concussive injury that aids clinicians in the assessment of patients at baseline, point of injury and through recovery, according to a news release. The index adds to BrainScope’s […]
BrainScope
BrainScope completes large-scale BrainScope One mTBI validation study
BrainScope said today that it completed a validation study of its BrainScope One device designed to assess head injuries, exploring its ability to assess mild traumatic brain injuries in adolescent and young adult populations. The Bethesda, Md.-based company ‘s FDA-cleared BrainScope One device is a multi-modal device designed to aid in the objective and rapid […]
FDA clears Brainscope’s concussion Dx device
BrainScope said today that it won FDA clearance to include new indication language for its BrainScope One concussion assessment device. Following a multi-parameter assessment, the company’s device can determine the likelihood of the presence and severity of a concussion or mild traumatic brain injury. “This additional FDA labeling for our product, BrainScope One, recognizes the unique […]
BrainScope lands $4.5M to add vision assessment to its technology
The U.S. Department of Defense has awarded BrainScope a $4.5 million research contract to create and integrate ocular capabilities into its handheld, multi-parameter mild traumatic brain injury (mTBI) and concussion products. The Bethesda, Md.-based company’s initial product, BrainScope One, is the first FDA-cleared medical device that can assess the full spectrum of brain injury – from concussions (functional […]
The 10 most innovative medical devices of 2018
The nominees for the best medical technology of 2018 were recently announced for the 12th Annual Prix Galien USA Awards. The host of the awards, The Galien Foundation, awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Before the candidates can qualify […]
The 11 most innovative medical devices of 2017
The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]
