US EditionTYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function
- TYBR Health announced FDA 510 clearance for its B3 GEL™ System on June 9, 2025, in Houston, Texas.
- TYBR developed B3 GEL to address the overlooked problem of unprotected healing after surgical procedures.
- B3 GEL is a biodegradable gel barrier developed to shield soft tissue layers and enhance healing outcomes following musculoskeletal surgical procedures.
- Preclinical research supporting FDA clearance indicated that B3 GEL minimized tissue adhesion and enhanced movement in treated subjects, showing better bending and straightening abilities than untreated controls, with supporting documentation available.
- TYBR aims to launch the B3 GEL System for commercial availability by the end of 2025, representing an important achievement for the company.
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TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function
/PRNewswire/ -- TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for...
·United States
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