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TELA Bio receives FDA 510(k) clearance for Liora Monofilament Scaffold
TELATELA Bio, Inc.
TELA Bio, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its Liora Monofilament Scaffold, a fully resorbable surgical mesh device designed for soft tissue reinforcement. This regulatory milestone marks the first implant to be fully developed in the company’s ISO 8 certified cleanroom in Malvern, Pennsylvania, and expands TELA Bio's portfolio of innovative soft-tissue reconstruction solutions. The clearance enables the commercial-stage medical technology company to broaden its footprint in the market by offering a new option for surgeons and patients that leverages natural healing responses while minimizing long-term exposure to permanent synthetic materials.