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Radiation Therapy / Small Business

ABK Biomedical Completes Enrollment in ROUTE90 Pivotal Study for Primary Liver Cancer

HALIFAX, NS, Feb. 24, 2026 /PRNewswire/ – ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic medical devices, today announced the completion…

Orthopedic / Small Business

ATRO Medical Secures €3 Million to Advance Artificial Meniscus Toward Pivotal Studies

ATRO Medical, the Dutch clinical-stage orthopedic company developing a novel artificial meniscus implant for patients suffering from post-meniscectomy pain, today announces the successful closing of a €3 million financing round.…

Artificial Intelligence (AI) / Regulatory Affairs

i-GENTIC AI Launches Context-Aware MedTech Agents to Strengthen FDA 510(k) Submission Consistency

PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of…

Health Access / Small Business

Catalyst OrthoScience Receives FDA 510(k) Clearance for Expanded Indications of the Fracture Shoulder System

NAPLES, Fla., Dec. 4, 2025 – Catalyst OrthoScience Inc. (“Catalyst”), a private medical technology company redefining shoulder arthroplasty through simplified, surgeon-focused innovation, today announced that its Catalyst Fracture Shoulder System has received…

Health Access / Small Business

Francis Medical Receives FDA 510(k) Clearance for Use of the Vanquish® Water Vapor System for Prostate Tissue Ablation in Patients with Intermediate Risk Prostate Cancer

MINNEAPOLIS (Dec. 2, 2025) – Francis Medical, Inc., a privately-held medical device company developing the breakthrough Vanquish® Water Vapor Ablation System for the management of prostate cancer, today announced that…

Carbon Medical Technologies’ BiomarC Fiducial Markers and BiomarC Restore Achieves EU MDR Certification

August 8, 2025 – Carbon Medical Technologies, Inc. (CMT), a manufacturer of implantable medical devices that utilize proprietary pyrolytic carbon coating technology, is proud to announce that both its BiomarC…

Breakthrough in Cancer Care: Multi4Medical’s New Technology Cleared by FDA

Swedish MedTech company Multi4 Medical, chaired by renowned investor Erik Selin, has received FDA clearance for its patented technology for automated cancer treatment. The decision means that Multi4 is now…

UroMems Receives Clearance from the FDA and the French ANSM for Initiating Landmark Pivotal Clinical Study of UroActive™ Smart Implant to Treat Male Stress Urinary Incontinence

GRENOBLE, France & MINNEAPOLIS, Minnesota (July 17, 2025) – UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), received investigational device exemption (IDE) approval from…

Monteris Medical Announces Largest Prospective Publication to Date in JAMA Neurology on LITT for Epilepsy Cohort Using the NeuroBlate® System

WOBURN, Mass. (July 7, 2025) – Sirtex Medical (“Sirtex”), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres® Y-90 resin…

Sirtex Medical’s SIR-Spheres® Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma

WOBURN, Mass. (July 7, 2025) – Sirtex Medical (“Sirtex”), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres® Y-90 resin…

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