January 29, 2025 Author(s): Matthew J. Mutter, MD Key Takeaways SHOW MORE “The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant,” says Matthew J. Mutter, MD. Signati Medical recently filed an application with the FDA for de novo market […]
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Signati™ Medical Successfully Completes IDE Trial for Separo™ Vessel Sealing System and Initiates FDA Market Clearance Process
Providence, RI, Dec. 23, 2024 (GLOBE NEWSWIRE) — Signati™ Medical is proud to announce the successful completion of its Investigational Device Exemption (IDE) trial evaluating the Separo™ Vessel Sealing System for vasectomy procedures. All eight patients enrolled in the study met the primary endpoint, marking a significant milestone in the development of this groundbreaking technology. […]
Signati Medical Announces Completion of Enrollment in First-in-Human Clinical Trial for Groundbreaking Sealed Vasectomy Procedure
Providence, RI, July 18, 2024 (GLOBE NEWSWIRE) — Signati Medical™, a medical device company dedicated to advancing men’s health, today announced the successful completion of enrollment in its Investigational Device Exemption (IDE) trial evaluating the safety and efficacy of its proprietary Signati Separo™ Vessel Sealing System for vasectomy procedures. This prospective IDE trial, initiated in […]
Signati™ Medical Enrolls First Patient in Groundbreaking Sealed Vasectomy Procedure Trial
Providence, RI, April 09, 2024 (GLOBE NEWSWIRE) — Signati™ Medical, a medical device company dedicated to advancing men’s health, today announced the successful enrollment of the first patient in its Investigational Device Exemption (IDE) trial for the Signati Separo™, a revolutionary new device designed to streamline the vasectomy procedure. This minimally invasive procedure utilizes the […]
Signati™ Medical, Inc. Receives FDA Approval for IDE Study
Providence, RI, Dec. 20, 2023 (GLOBE NEWSWIRE) — The FDA has officially approved Signati™ Medical’s Investigational Device Exemption (IDE) study! This comes on the company’s 5 year anniversary. “Our investments in research and development along with technological advancements have enabled Signati to develop the first minimally invasive vasectomy product in a market that is on […]
A Rhode Island medical device company that’s working to transform the vasectomy process is celebrating a milestone.
A Rhode Island medical device company that’s working to transform the vasectomy process is celebrating a milestone. Signati Medical, based in Providence, in December gained FDA approval for a clinical study, and hopes to bring its noninvasive vasectomy device to market in the third quarter, CEO William Prentice told Business First. The device will let a doctor perform a “sealed vasectomy procedure,” or SVP, in a matter of minutes using a desktop generator and hand-held device. The proprietary device doesn’t puncture a man’s scrotum, and instead seals the vas deferens via an electronic signal. That’s opposed to current methods for male sterilization, which are far more […]