Separo Vessel Sealing System
NDA- Indications
- Vasectomy
Company intelligence / Profile preview
Signati Medical has completed a first-in-human Investigational Device Exemption (IDE) clinical trial of its proprietary Separo™ Vessel Sealing System for vasectomy. The study enrolled eight patients and met its primary endpoint with no device-related adverse events. The company is now preparing a De Novo submission to the FDA seeking market clearance. The device is not yet approved or marketed in any country.
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