SafeHeal® Receives European Marketing Approval Under MDR for Colovac® Anastomosis Protection Technology
PARIS, France — SafeHeal®, a leading innovator in the field of colorectal cancer surgery, today announced that it has been granted European Union marketing approval for its Colovac device under the new Medical Device Regulation (EU MDR 2017/745, Medical Devices, Annex IX Chapter I). This significant milestone confirms the company’s compliance with the EU’s rigorous safety and performance standards, enabling commercial distribution of Colovac across the European Union. Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal cancer resection.
