TORONTO – Imaging company Moleculight Inc. has launched a new point-of-care, wound imaging platform intended for multiple U.S. health care settings and has also inked a deal with a U.S. distributor to ensure it gets there.
Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan.
Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.