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 density (BMD).
Rho leverages a patented AI approach to identify bone loss at an early stage. It automatically scans eligible x-rays (frontal projections of the chest, thoracic spine, lumbar spine, pelvis, knee and hand/wrist) and alerts radiologists of patients with possible low BMD. Including this finding in an x-ray report is intended to trigger healthcare providers to perform a clinical fracture risk assessment of patients who would benefit, with no additional imaging time or radiation exposure.
Improved screening with software such as Rho, in combination with effective treatments, could help decrease the burden of osteoporosis-related costs in healthcare.
About 16 Bit Inc.
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...
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 density (BMD).
Rho leverages a patented AI approach to identify bone loss at an early stage. It automatically scans eligible x-rays (frontal projections of the chest, thoracic spine, lumbar spine, pelvis, knee and hand/wrist) and alerts radiologists of patients with possible low BMD. Including this finding in an x-ray report is intended to trigger healthcare providers to perform a clinical fracture risk assessment of patients who would benefit, with no additional imaging time or radiation exposure.
Improved screening with software such as Rho, in combination with effective treatments, could help decrease the burden of osteoporosis-related costs in healthcare.
About 16 Bit Inc.
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