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FDA Grants De Novo Marketing Authorization for Rho!

Rho is the FDA's first authorized radiology software for opportunistic evaluation of low bone mineral density (BMD).
News
April 12, 2024
FDA Grants De Novo Marketing Authorization for Rho!

On Tuesday, the FDA authorized marketing of Rho. signifying the first FDA-authorized radiology software for opportunistic evaluation of low bone mineral density (BMD). As described in our press release, Rho leverages a patented artificial intelligence approach to identify bone loss at a much earlier 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. Importantly, lifestyle modifications, in addition to both pharmacologic and non-pharmacologic therapies, are effective options for prevention and treatment. Annual osteoporosis-related costs are expected to increase from $57 billion to over $95 billion by 2040, but by improving screening with software such as Rho, in combination with effective treatments, this burden could be decreased.