Non-Contact Vascular Access Monitor for Dialysis Earns FDA Breakthrough Designation
The AI-driven optical system is designed for early detection of stenosis in hemodialysis patients and to reduce clinical staff workload.
Tag: FDA Breakthrough Device Designation
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MITA Expresses Concern to CMS About Proposed TCET Program
MITA expressed concern about the scope and utility of the proposed notice for the TCET program in its submitted comments to the CMS.
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MCRA Helped Grant More Than 60 Breakthrough Device Designations
MCRA says it has successfully helped over 60 breakthrough device designations get granted by the U.S. FDA.
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Non-Contact Vascular Access Monitor for Dialysis Earns FDA Breakthrough Designation
The AI-driven optical system is designed for early detection of stenosis in hemodialysis patients and to reduce clinical staff workload.
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.
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Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation
Sensome has been granted a Breakthrough Device designation by the FDA for its Clotild Smart Guidewire System designed to improve the treatment of ischemic stroke patients.
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VoluMetrix’s NIVA|HF for Heart Failure Patients Designated as FDA Breakthrough Device
NIVA|HF is an investigational device designed to monitor the venous waveform in heart failure patients using VoluMetrix's Non-Invasive Venous waveform Analysis (NIVA) technology.
