Tag: FDA Breakthrough Device Designation

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AI Tool for Drafting Radiology Reports Receives FDA Breakthrough Status

The system creates preliminary report text from chest X-rays and is intended to support radiologists facing increasing workloads.

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New Artificial Heart Technology Earns FDA Breakthrough Device Designation

The clinical-stage company earns the regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use.

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Innoblative SIRA RFA Gets FDA Breakthrough Device Designation

Innoblative's SIRA RFA Electrosurgical Device is intended for use in breast cancer patients undergoing BCS.

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AI Tool for Drafting Radiology Reports Receives FDA Breakthrough Status

The system creates preliminary report text from chest X-rays and is intended to support radiologists facing increasing workloads.

Dexcom Continuous Glucose-Monitoring System Nabs FDA Breakthrough Device Designation

Mar 2, 2022

Dexcom has been granted FDA Breakthrough Device Designation of its new continuous glucose monitoring system for use in the hospital setting.

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

Feb 24, 2022

Noninvasix’s LIVOx Central Venous Oxygenation Monitor has received Breakthrough Device Designation from the FDA for non-invasive Sepsis monitoring tech.

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

Feb 3, 2022

CardiAMP Cell Therapy technology uses a patient’s bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure.

Philips Laser Assisted IVC Filter Removal Gets FDA De Novo Clearance

Dec 21, 2021

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.

Concussion Therapy Tool Receives FDA Breakthrough Device Designation

Nov 4, 2021

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.

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

Oct 20, 2021

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.