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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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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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.

Tag: FDA Breakthrough Device Designation

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RenalGuard Therapy Gets Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI

Opticyte’s Patient Monitor for Organ Failure Earns Breakthrough Device Designation

CorVista Gets Breakthrough Device Designation for Pulmonary Hypertension Diagnostic Solution

MCRA Helped Grant More Than 60 Breakthrough Device Designations

Anumana’s ECG PH Early Detection AI Algorithm Gets Breakthrough Device Designation

New PTSD Treatment Gets FDA Breakthrough Device Designation

Dexcom Continuous Glucose-Monitoring System Nabs FDA Breakthrough Device Designation

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Non-Invasive Monitor Tech for Sepsis Gets FDA Breakthrough Device Designation

BioCardia’s Cell Therapy System for Heart Failure Gets FDA Breakthrough Device Designation

Philips Laser Assisted IVC Filter Removal Gets FDA De Novo Clearance

Concussion Therapy Tool Receives FDA Breakthrough Device Designation

U.S. FDA Grants Breakthrough Device Designation for Sonic Beam Therapy

U.S. FDA Grants Breakthrough Device Designation for EndoSound Vision Ultrasound System

FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris System

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Endologix ChEVAS System Gets FDA Breakthrough Device Designation

Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation

VoluMetrix’s NIVA|HF for Heart Failure Patients Designated as FDA Breakthrough Device

FDA Grants Breakthrough Device Designation for Smart Orthopedic Implants

IceCure Medical Granted FDA Breakthrough Device Designation for ProSense Cryoablation System

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RenalGuard Therapy Gets Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI

Opticyte’s Patient Monitor for Organ Failure Earns Breakthrough Device Designation

CorVista Gets Breakthrough Device Designation for Pulmonary Hypertension Diagnostic Solution

MCRA Helped Grant More Than 60 Breakthrough Device Designations

Anumana’s ECG PH Early Detection AI Algorithm Gets Breakthrough Device Designation

New PTSD Treatment Gets FDA Breakthrough Device Designation

Dexcom Continuous Glucose-Monitoring System Nabs FDA Breakthrough Device Designation

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