CHICAGO, June 25, 2025 /PRNewswire/ — Sysmex America, Inc., a leading diagnostic solutions company offering hematology, hemostasis, urinalysis, flow cytometry and informatic solutions, has received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer.
Tissium announced today that it received FDA de novo marketing authorization for Coaptium Connect with Tissium Light.
Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA).
CAESAREA, Israel, June 24, 2025 /PRNewswire/ — Nitinotes, developer of the EndoZip™ System, a fully automated suturing platform for endoscopic sleeve gastroplasty (ESG), today announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial under an Investigational Device Exemption (IDE).
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.
Brain-computer interface (BCI) developer Science Corporation today said it submitted its Prima retinal implant for CE mark approval.
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.
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.
Wearable Device Now Authorized to Support Diagnosis and Monitoring of Sleep Apnea and Related Health Conditions from the Comfort of Home
Magnetic-Assisted Robotic Platform Now Approved for Bariatric and Hiatal Hernia Procedures, Broadening Access to Scar-Reducing Surgical Innovation