International product information

The product details shown after you switch describe the versions of Rho authorized outside the United States, including the Rho Score, which is not part of the US version.

US product information

The product details shown after you switch describe the version of Rho authorized in the United States, which reports whether a patient is Rho Positive.

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Regulatory

Health Canada licenses Rho as a Class II medical device

Ottawa. Health Canada issued medical device licence 107916 for Rho, 16 Bit's opportunistic screen for low bone mineral density from standard X-rays, allowing its sale and clinical use in Canada.

Rho analyzes frontal X-rays of the chest, thoracic spine, lumbar spine, pelvis, hand or wrist, and knee taken for other reasons in patients aged 50 and older, and sends a report to PACS when a patient is likely to have low bone mineral density. The licence followed a proof-of-concept study with the Canadian Multicentre Osteoporosis Study and a development program supported by INOVAIT.

Canada was Rho’s first market. Deployments in community imaging and hospitals followed in 2023.