GeneseeqPrime Gains FDA 510(k) Clearance for Tumor Profiling Kit
TORONTO, Sept. 2, 2025 – Geneseeq Technology Inc. announced that its GeneseeqPrime® NGS Tumor Profiling Assay has received 510(k)...
Medical Devices, Diagnostics, Radiation-Emitting Products
FDA TRG Classifies Five Amniotic Membrane Allografts as HCT/Ps
PHOENIX, August 28, 2025 — Five amniotic membrane allograft products have received official recognition from the FDA’s Tissue Reference...
Phraxis Marks First Commercial Use of EndoForce Anastomotic Connector
MINNEAPOLIS, August 29, 2025 — Phraxis announced the successful completion of the first-ever commercial case using its EndoForce Anastomotic...
Imbed Biosciences Gains FDA IDE for Silver-Gallium Wound Matrix Trial
Imbed Biosciences has announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE)...
Terumo Acquires OrganOx: A New Era in Organ Preservation
Terumo Corporation is acquiring UK-based OrganOx Limited for approximately USD 1.5 billion, enhancing its entry into the organ transplantation...
SmartAlpha’s Ultrasound AI Software Nerveblox Gains FDA 510(k) Approval
ANKARA, Türkiye, August 18, 2025 — SmartAlpha’s AI-powered software, Nerveblox, designed to assist clinicians performing ultrasound-guided regional anesthesia (“nerve...