FDA Adds RevMedica Stapling Platform To STeP Program

RevMedica announced that the FDA has accepted its Endo stapling platform into the Safer Technologies Program (STeP).

STeP is a collaborative initiative designed to expedite the development and approval process for eligible devices. Launched by the FDA in 2021, the program is modeled after its breakthrough devices designation program. It targets devices that could enhance the safety of treatments or diagnostics for less serious conditions compared to those eligible for breakthrough designation.

Based in Middletown, Connecticut, RevMedica also expanded its intellectual property portfolio, receiving five new U.S. patents, bringing its total to 20 U.S. patents and five foreign patents.

RevMedica’s mission is to transform soft tissue management in surgery, aiming to improve clinical decision-making and enhance patient safety with cost-effective, environmentally friendly solutions.

“The STeP designation validates the unique benefits of our stapling platform,” said Tom Wenchell, CEO. “It reflects years of feedback from surgeons who identified a need for objective, real-time data, which current stapling devices lack. We're fortunate to have a skilled team of surgical stapling experts to bring this product to life.”

“We are committed to building a strong foundation for our innovation and protecting these advancements both domestically and internationally,” Tom added.