EMVision Medical Devices is developing a second-generation helmet scanner, designed for road and air ambulance deployment, for bench testing.
The 28-antenna prototype helmet scanner aims to address an unmet clinical need in both bedside and first responder brain imaging. The first-generation scanner is addressing the bedside need in multisite clinical trials.
The headset weighs under 22 lb and is intended to be transported to the point-of-care via a backpack. It contains a 28-antenna 3D array designed to provide entire brain coverage in a single scan. A silicone membrane with coupling media connects the antennas to the head.
The bench testing will assess a range of technical parameters compared to simulations, leading to target detection investigations. EMVision recently submitted an ethics submission for healthy human volunteer testing. This testing intends to evaluate usability, ergonomics, and signal benchmarking.
The company added that it aims to leverage the first-generation scanner as a predicate device to pursue 510(k) clearance by the U.S. Food and Drug Administration for the second-generation scanner.
