Designed for long-term monitoring and patient comfort, EmbraceMini sets a new benchmark in wearable technology for decentralized and real-world evidence studies.
Next-Generation Ankle Replacement Platform Designed to Improve Surgical Precision and Patient Outcomes in Orthopaedic Care
Breakthrough Integrated Sacral Neuromodulation Device Approved to Treat Urinary Urge Incontinence with a Minimally Invasive, Patient-Centric Approach
Next-Generation Stent Designed to Prevent Stroke by Combining Embolic Protection and Advanced Plaque Management in Carotid Artery Disease
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.