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Digital Health / Health Access

Gravitas Medical Launches Multicenter NICU Study of Next-Generation Smart Feeding Tube System

BERKELEY, Calif., April 21, 2026 — Gravitas Medical, Inc., a developer of advanced enteral feeding technologies, today announced the initiation of a prospective, multicenter clinical study evaluating its next-generation (Gen…

Regulatory Affairs / Small Business

Carbon Medical Technologies’ InjecSURE® Injection System Receives FDA 510(k) Clearance, Expanding CMT’s Portfolio of Urology Delivery Solutions

Saint Paul, MN – April 15, 2026. Carbon Medical Technologies, Inc. (CMT), a manufacturer of implantable medical devices and delivery systems utilizing proprietary technologies, is pleased to announce that its…

Diagnostics / Medical Imaging

Perimeter Medical Imaging AI’s ‘Claire’ Becomes First FDA-approved AI-Enabled Imaging Device for Breast Cancer Surgery

TORONTO and DALLAS, March 3, 2026 /PRNewswire/ – Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) (“Perimeter” or the “Company”), a commercial-stage medical technology company, announced today that it has received U.S.…

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…

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