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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.
FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis
The RhinAer™ Stylus, an innovative device for nonsurgical treatment of chronic rhinitis.
Magnolia Medical Announces (FDA) 510(k) Clearance of New Configurations and the Entire Steripath® Gen2 Initial Specimen Diversion Device® Product Family
Magnolia Medical products become the first and only indicated to reduce blood culture contamination.
FDA Designation of Basal-IQ Technology as an Interoperable Automated Glycemic Controller Announced by Tandem Diabetes Care
The company reports this is the second system to receive iAGC designation by the FDA, following the Company’s clearance of the t:slim X2™ insulin pump with Control-IQ™ technology in December 2019.
FX Solutions Receives FDA 510k Clearances for Glenoid Baseplate With a Central Screw and 32mm Glenosphere and Humeral Cups
FX Solutions notes the addition of the glenoid baseplate with a central screw allows surgeons perioperative options to address a variety of deficiencies and can now accommodate an even larger patient population and surgeon's needs.
Novalung ® for Treatment of Acute Respiratory and Cardiopulmonary Failure Receives FDA Clearance
Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support.
Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance
Luminex notes the GI Flex Assay is an automated test for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples.
Canon Medical Receives FDA Clearance for Aquilion ONE / PRISM Edition, Enabling Deep Learning Spectral Capabilities for Routine Use
Designed for deep intelligence, Canon Medical notes the advanced system integrates artificial intelligence (AI) technology to maximize conventional and spectral CT capabilities with automated workflows, while providing deep clinical insights to assist physicians in making more informed decisions across the patient’s care cycle.
Flowonix Receives FDA Approval to Market Prometra® II Pump
Flowonix notes the new indication expands significantly the market for the Prometra device by enabling its use in the treatment of spasticity.
Acutus Medical Secures FDA Clearance and CE Mark for SuperMap™
Acutus Medical notes the SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias.