FDA specifically noted the lack of a comparable predicate device for use as an aid in visualizing and documenting abnormalities of the prostate detected by digital rectal examination. The company intends to discuss this letter and its findings with the FDA as soon possible and also plans to explain why it believes there is a suitable predicate.

If the ProUroScan system is not found to be substantially equivalent because a suitable predicate cannot be identified, the FDA may indicate that the product may be appropriate for a ‘de novo’ or ‘risk-based’ classification.

The path is intended to allow low-risk devices to be marketed under a 510(k) when there is no adequate predicate. Information supporting the de novo application would then be combined with the previously submitted 510(k) application and re-submitted to the FDA for review.

Rick Carlson, CEO of ProUroCare, said: “We remain optimistic about the regulatory status of the system, and believe the FDA will recognize the ProUroScan as a low-risk device that can be cleared under either the 510(k) application or the de novo process. We will provide additional information after we receive further clarification of the regulatory path with the FDA.”