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.
Tag: FDA Breakthrough Device Designation
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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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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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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.
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.
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FDA Grants Breakthrough Device Designation for Smart Orthopedic Implants
Intelligent Implants SmartFuse technology is a wirelessly enabled orthopedics platform that has been designed to remotely stimulate, control, and monitor bone growth.
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IceCure Medical Granted FDA Breakthrough Device Designation for ProSense Cryoablation System
The U.S. FDA has granted cryoablation technology developer IceCure Medical Ltd. Designation as a Breakthrough Device for its lead product, ProSense, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer.
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