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

FDA grants Breakthrough Device designation to Rho

Toronto. The US Food and Drug Administration granted Rho Breakthrough Device designation, a program for devices that may offer more effective diagnosis of irreversibly debilitating conditions. The designation gives 16 Bit priority review and interactive communication with the agency during its submission.

The FDA does not publish the names of designated devices or the dates of designation. 16 Bit received the designation in March 2021.

Breakthrough designation does not authorize marketing. Rho was authorized for the US market in April 2024 through the De Novo pathway.