Signati™ Medical has officially filed their IDE study with the FDA. An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
Providence, RI, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Signati™ Medical has officially filed their IDE study with the FDA. An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. All clinical evaluations of investigational devices must have an approved IDE before the study begins. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.
Signati’s™ GLP data shows that their device has met safety endpoints of sealing, no thermal spread, and clinically documented wound healing. The IDE study will be the final step for Signati™ to market their Sealed Vasectomy Procedure (SVP)™ to the public once fully approved by the FDA.
About Signati™ Medical, Inc.
Signati™ Medical, Inc. is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati Sealed Vasectomy Procedure (SVP)™, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques. To learn more, visit www.signatimed.com.
Not approved by the Food and Drug Administration (FDA). These statements and the subject product have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease. The device is not currently being marketed, nor is it available for sale in any country.
William Prentice President & CEO, Signati Medical Inc. 128 Dorrance Street 6th Floor Providence, RI 02903 william.prentice@signatimed.com https://signatimed.com
