Tag: FDA Breakthrough Device Designation

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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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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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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.

IceCure Medical Granted FDA Breakthrough Device Designation for ProSense Cryoablation System

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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.

Tag: FDA Breakthrough Device Designation

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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

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

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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

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

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FDA Grants Breakthrough Device Designation for Smart Orthopedic Implants

IceCure Medical Granted FDA Breakthrough Device Designation for ProSense Cryoablation System

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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

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

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