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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices™ Cardiopulmonary Management (CPM) System
Sensinel is a compact wearable device is a non-invasive, remote management system that captures cardiopulmonary measurements for chronic disease management such as heart failure. It is the first FDA clearance the company has received in its 59-year history.
Boston Scientific Receives FDA Approval for the AGENT™ Drug-Coated Balloon
The AGENT DCB is available in Europe, parts of Asia Pacific and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease. Boston Scientific plans to launch the technology in the U.S. in the coming months.
FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer
Tabrecta is the first FDA-approved therapy to treat non small cell lung cancer with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping).
CorMatrix Cardiovascular Receives FDA Approval to Expand and Enroll 20 Additional Patients in the Adult Arm of its Early Feasibility IDE study of the Cor®...
The Cor® TRICUSPID ECM® valve has been successfully implanted in the 11th patient enrolled in the expansion by Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center in Indianapolis, Indiana & principal investigator for the adult component of the study.