Neuromedical Systems, Inc.
This article was originally published in The Gray Sheet
Executive Summary
Submits a premarket approval application to FDA for the Papnet testing system, which examines Pap smear sample cells to aid in the manual diagnosis of cervical cancer. The company says the PMA submission includes the results from a 10-laboratory, 12,052- sample, 10,003-patient clinical trial conducted over an 18-month period. In July, Neuromedical Systems was projecting that it would submit the PMA early next year ("The Gray Sheet" July 25, p. 16)