16Bit receives FDA De Novo marketing authorization for Rho™

16 Bit Inc., a software medical device company, recently announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo marketing authorization for Rho™, an AI-enabled software device aimed at improving a known care gap in osteoporosis screening. Rho received Breakthrough Device designation by the FDA in March 2021, signifying the first FDA-authorized radiology software for opportunistic evaluation of low bone mineral density (BMD).

16Bit is an alumnus of our BDSP™ and H2BB™ programs, presented at the OBIO® Investment Summit, and is a part of our Life Sciences Critical Technologies & Commercialization (LSCTC) Centre of Excellence technology adoption stream.