TELA Bio, Inc. announced on October 5, 2026, that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Liora Monofilament Scaffold product. The device is a fully resorbable surgical mesh designed for soft tissue reinforcement. The company stated that this clearance represents the first fully resorbable synthetic product in its portfolio to be designed and produced in-house.
The Liora product was manufactured in TELA Bio's ISO 8 certified cleanroom located in Malvern, Pennsylvania. The company noted that the addition of Liora to its portfolio will expand the options available to surgeons and patients for soft tissue reconstruction needs. Heather Getz, the Chief Executive Officer of TELA Bio, commented on the milestone, describing the clearance as significant for the company.
TELA Bio is a commercial-stage medical technology company focused on soft-tissue reconstruction. The company stated that it is committed to providing surgeons with advanced, economically effective solutions that leverage the patient's natural healing response while minimizing long-term exposure to permanent synthetic materials. The company indicated that it will provide more details regarding the product during its upcoming third quarter earnings call, which is expected to be hosted in early November.
