CMS and FDA Launch RAPID Pathway to Speed Access to Breakthrough Medical Devices
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
Tag: FDA Breakthrough Device Designation
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FDA Grants Restore Medical ContraBand Breakthrough Designation
Restore Medical's ContraBand device received FDA Breakthrough Device Designation for treating heart failure with reduced ejection fraction.
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RenalGuard Therapy Gets Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI
The FDA granted Breakthrough Device Designation for CardioRenal Systems' RenalGuard Therapy device for the prevention of acute kidney injury.
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CMS and FDA Launch RAPID Pathway to Speed Access to Breakthrough Medical Devices
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
Non-Invasive Monitor Tech for Sepsis Gets FDA Breakthrough Device Designation
Noninvasix’s LIVOx Central Venous Oxygenation Monitor has received Breakthrough Device Designation from the FDA for non-invasive Sepsis monitoring tech.
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BioCardia’s Cell Therapy System for Heart Failure Gets FDA Breakthrough Device Designation
CardiAMP Cell Therapy technology uses a patient’s bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure.
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Philips Laser Assisted IVC Filter Removal Gets FDA De Novo Clearance
The FDA granted De Novo Clearance for the Philips Inferior Vena Cava Filter Removal Laser Sheath to remove an IVC filter when other methods have failed.
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Concussion Therapy Tool Receives FDA Breakthrough Device Designation
The U.S. FDA has awarded Breakthrough Device designation to TecTraum’s pro2cool system, a hypothermic therapy device that provides localized cooling to reduce the severity of sports-related concussions.
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U.S. FDA Grants Breakthrough Device Designation for Sonic Beam Therapy
Breakthrough status for histotripsy targeted liver therapy will help provide timely access to noninvasive liver treatment, according to HistoSonics.
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U.S. FDA Grants Breakthrough Device Designation for EndoSound Vision Ultrasound System
The EndoSound Vision System is an add-on device that consists of a compact ultrasound beam-former, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal video endoscope to convert it into an endoscopic ultrasound system.
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FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris System
Ohio-based Synapse Biomedical, Inc. announces that the U.S. FDA has granted Breakthrough Therapy Device designation to TransAeris, a temporary percutaneous intramuscular diaphragm stimulator designed to aid in weaning from mechanical ventilation.
