MedTech News

TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function

HOUSTON, June 9, 2025 /PRNewswire/ — TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL™ System. B3 GEL™ is a bioresorbable, flowable gel barrier designed to protect healing tissue planes and preserve mobility following surgeries involving tendons, ligaments, and skeletal muscle.

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Solventum Launches Preassembled, See-through VH2O2 Test Pack for Low-temp Medical Instrument Sterilization

ST PAUL, Minn., June 9, 2025 /PRNewswire/ — Solventum, a global MedTech leader at the forefront of infection prevention innovation, today announced the launch of its Attest™ Super Rapid Vaporized Hydrogen Peroxide (VH2O2) Clear Challenge Pack. The ready-to-use test integrates two previously FDA-cleared indicators – a biological indicator (BI) for confirming microbial neutralization and a chemical indicator (CI) for verifying proper sterilizer function – into a single-use test pack with a transparent container.

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