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Signati Medical Receives FDA IDE Approval for Pivotal Trial of Separo Vasectomy System

Shots: The FDA has granted IDE approval to initiate a multi-center pivotal study evaluating the Separo Vessel Sealing System vs standard mucosal cautery vasectomy The trial will enroll 120 adult male subjects across ~5 US centers, with the primary endpoint measuring azoospermia or rare non-motile sperm (≤100,000/mL) within 6mos. following the procedure The Separo System…

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