UHN's start-up MolecuLight® Inc receives FDA De Novo clearance - Readies to enter the US wound care market
Toronto-based, University Health Network (UHN) start-up company, MolecuLight® Inc. announced today that it has achieved a key regulatory milestone by receiving FDA's De Novo clearance for a first-of-its-kind handheld fluorescence imaging device, the MolecuLight i:X.
The MolecuLight i:X device captures and documents digital fluorescence information from wounds and tissue surrounding the wound site with real time videos and still images. This point-of-care device has been optimized to be portable, compact, and eliminates the use of contrast agents.
MolecuLight® Inc., will now be able to provide the MolecuLight i:X as a prescription-use only point-of-care imaging device to clinicians in the USA. In turn, clinicians will gain a much needed tool to make improved decisions about the diagnosis and treatment of patients' dermal wounds when the wound sites are exposed to excitation light.
The MolecuLight i:X device has already received the Health Canada Medical Device License (2015) and the European CE Mark (2016). With FDA's marketing authorization, MolecuLight® Inc., continues its global expansion of its initial flagship product and accessories.
For more information and to read the full story click on the hyperlink: https://moleculight.com/news/moleculight-inc-first-of-its-kind-handheld-fluorescence-imaging-device-receives-fda-de-novo-clearance-for-us-wound-care-market/.