RevMedica announced that the FDA accepted its Endo stapling platform into its Safer Technologies Program (STeP).
STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program.
The program covers devices that could improve the safety of treatments or diagnostics. They treat underlying diseases or conditions considered less serious than those treated or diagnosed by devices eligible for breakthrough designation.
Middletown, Connecticut–based RevMedica also expanded its intellectual portfolio through the issuance of five new U.S. patents. This brings it to 20 U.S.- and five foreign-issued patents.
RevMedica aims to revolutionize the way surgeons approach soft tissue management. It seeks to optimize clinical decision-making and elevate patient safety with cost-effective, environmentally friendly surgical systems.
“The STeP designation offers additional validation of the unique advantages of our stapling platform,” said Tom Wenchell, CEO. “This is the product of many years spent listening to surgeons describe their need for objective, real-time data currently lacking in today’s stapling devices. We are fortunate to have such an experienced team of surgical stapling experts on staff to make this product a reality.”
“We continue to build a strong foundation to bolster our unique offering and will continue to protect these advancements in the U.S. and abroad,” concluded Tom.