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Final decision for NeoPath's primary screener soon:

This article was originally published in Clinica

Executive Summary

NeoPath, the first company to receive an FDA panel approval recommendation for primary use of its automated cervical screening device, said it expected to resolve conditions laid down by the panel shortly (see Clinica No 794, p 15). Labelling conditions, which must be resolved before the company's AutoPap system can be approved, were identified in a letter to the company from the FDA. "The FDA states that it is committed to providing the company with a decision letter on its PMA as soon as possible" said the company.






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