AI Multi-Triage Solution Earns FDA Breakthrough Designation
The designation will expedite the review process for the CT-based artificial intelligence, which flags numerous acute conditions simultaneously.
Tag: FDA Breakthrough Device Designation
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FDA Approves DermaSensor Skin Cancer Evaluation System
DermaSensor received FDA clearance for its AI-powered, real-time, non-invasive skin cancer evaluation system.
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Opticyte’s Patient Monitor for Organ Failure Earns Breakthrough Device Designation
Opticyte's Cell Oâ‚‚ Patient Monitor has received Breakthrough Device Designation for the continuous monitoring of those at risk of organ failure.
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AI Multi-Triage Solution Earns FDA Breakthrough Designation
The designation will expedite the review process for the CT-based artificial intelligence, which flags numerous acute conditions simultaneously.
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.
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Endologix ChEVAS System Gets FDA Breakthrough Device Designation
The ChEVAS System is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal, and suprarenal AAA.
