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FDA
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.
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.
Thirona receives FDA 510(k) Clearance for LungQ v3.0.0 Software to Power AI Analysis of Chest CT Images
Thirona notes LungQ 3.0.0 builds on 10 years of clinical trials and 200+ publications to deliver advanced segmentation of pulmonary segments and subsegments.
Zeta Surgical Reports Mixed Reality Navigation System Receives FDA Special 510(k) Clearance for Expanded Functionality
The Zeta Surgical Cranial Navigation System is a mixed-reality navigation system for neurosurgery, providing surgeons with "GPS-like" guidance with millimetric accuracy in real-time. Zeta's computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement, and allowing for awake and non-immobilized use in both operative and extra-operative settings.
U.S. FDA Approves the VISUMAX 800 with SMILE Pro Software from ZEISS
The updated ZEISS femtosecond laser provides U.S. refractive surgeons with faster treatment, greater flexibility, and significant workflow enhancements.
Enspectra Health Announces US FDA Clearance of VIO™ System, 1st of Its Kind Technology to Visualize Skin Cellular Structures in Real-Time
Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health. "This significant achievement is the result of the excellent work by the Enspectra Health team and our clinical advisors. Our submission was cleared by the FDA ahead of plan, underscoring our ability to successfully drive an innovative technology from concept to clearance."
PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval Reports Pulnovo Medical
The PADN technology is a major revolutionary procedure in the field of global interventional pulmonary arterial hypertension (PAH), which breaks the dilemma in PAH interventional therapy.
CGBio’s ‘NOVOSIS PUTTY’ Receives FDA ‘Breakthrough Device Designation,’ Accelerate Entry into the US Market
NOVOSIS PUTTY: The designation marks the first case for implantable device in Korea. Despite being a high-risk permanent implant, NOVOSIS PUTTY's efficacy and innovative aspects are recognized internationally.
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