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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).
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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.