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. Read More
Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology. Read More
Spinal cord stimulation to treat pain has long been associated with mixed efficacy and substantial side effects such as paresthesia, which is an unpleasant tingly or prickly sensation. Redwood City, Calif.-based Nevro Corp. famously has built a multi-billion-dollar business on next-gen, pain neurostimulation technology that improves efficacy and reduces side effects. Sommerville, Mass.-based Micro-leads Medical Inc. hopes that it could be next in successfully further refining spinal cord stimulation. Read More
The Watchman left atrial appendage device, distributed by Marlborough, Mass.-based Boston Scientific Corp., holds a unique place in the annals of med tech regulation, but 50-month data from two registries show a lower rate of hemorrhagic stroke than previously reported for the device. Read More
The Chapel Hill, N.C.-based non-profit Digital Health Institute for Transformation (DHIT) and Tanjo Inc., a machine learning company headquartered in Carrboro, N.C., will launch their Community Health Utility Grid (HUG) Initiative in North Carolina in early 2020. The collaboration aims to improve healthcare outcomes for underserved populations in the state by collecting, analyzing, and sharing individual, household and community level health data. Read More
