FDA De Novo for 16 Bit Bone Density Screening Tool

16 Bit was granted FDA De Novo marketing authorization for Rho, an artificial-intelligence-enabled software device aimed at improving a known care gap in osteoporosis screening. Rho received Breakthrough Device designation by FDA in 2021, signifying the first FDA-authorized radiology software for opportunistic evaluation of low bone mineral...

document icon

You are out of free articles for this month

Subscribe as a Guest for $0 and unlock a total of 5 articles per month.

You are out of five articles for this month

Subscribe as an Executive Member for access to unlimited articles, THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT and more.


Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

Contact Us