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Home » CORRELOGIC ALTERS OVACHECK TO AVOID PMA SUBMISSION
CORRELOGIC ALTERS OVACHECK TO AVOID PMA SUBMISSION
August 6, 2004
Correlogic Systems has decided to move a software program for its OvaCheck ovarian cancer-screening tool in-house to avoid submitting a premarket approval (PMA) application for the program. The decision follows an FDA ruling that classified the program as a medical device.