MedTech News

Cerapedics Announces FDA Approval of PearlMatrix™ P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator for Lumbar Fusion
WESTMINSTER, Colo., June 23, 2025 /PRNewswire/ — Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the U.S. Food and Drug Administration (FDA) premarket approval (PMA) of PearlMatrix™ P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for use in single-level transforaminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD). Despite the availability of over 350+ spinal bone grafts, none have demonstrated a substantial improvement in fusion speed until now. Powered by a proprietary P-15 Osteogenic Cell Binding Peptide, PearlMatrix Bone Graft is the first and only bone growth accelerator (BGA) proven to accelerate lumbar fusion.

MolecuLight Unveils Advanced Multimodal Imaging with Thermal Capabilities at St. Louis Wound & Vascular Symposium
New imaging innovation enhances wound assessment by combining fluorescence and thermal data for improved diagnostic precision and patient care

Meril Launches MyClip, India’s First Transcatheter-Edge-to-Edge Repair (TEER) System for Treatment of Severe Mitral Regurgitation
Meril Life Sciences, a leading global med-tech company, marked a significant milestone with the launch of MyClip, India’s first Transcatheter Edge-To-Edge Repair (TEER) system, on June 14

Science submits BCI for vision restoration for CE mark
Brain-computer interface (BCI) developer Science Corporation today said it submitted its Prima retinal implant for CE mark approval.

A new way to monitor glucose: Glucotrack explains 3-year CBGM implant technology
Glucotrack (Nasdaq:GCTK) believes it can tap into a diabetes market that includes millions of people who aren’t being served completely.

Breaking: Sequel to launch twiist automated insulin delivery system next month
Sequel Med Tech announced at the American Diabetes Association’s 85th Scientific Sessions in Chicago that it plans to launch its twiist system in July.

Ambu wins FDA clearance for first single-use cysto-nephroscope
Ambu announced it has received expanded FDA 510(k) clearance for its aScope 5 Cysto HD, making it the first single-use flexible cysto-nephroscope cleared for use in percutaneous nephrolithotomy (PCNL) procedures in the U.S.

Cube Click, Inc. Secures FDA Approval for SMILE Dx—A Game-Changer in Dental AI Diagnostics
FDA clearance positions SMILE Dx as a pioneering AI-powered platform for early detection and diagnosis in dental care, streamlining clinical workflows and improving patient outcomes.