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The PoNS device is a medical technology that helps individuals with chronic neurological symptoms caused by disease or trauma. It consists of a controller and a mouthpiece that delivers mild ā¦
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is a medical device that is indicated for the low-pressure balloon dilatation of severely calcified, ā¦
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
The INTERCEPT Blood System for Plasma is a pathogen reduction system that has been designed to reduce the risk of transfusion-transmitted infections (TTI) and transfusion-associated graft-versus-host ā¦
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
NightWare is a prescription digital therapeutic device that has been designated as a Breakthrough Device by the FDA in 2020. This designation is given to new treatments that address life-threatening ā¦
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
The MiniMed⢠770G system is a device that aims to aid in the management of diabetes. It offers features that can help to improve the quality of sleep and rest for users. Additionally, the system ā¦
Published Jan 19, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
FoundationOne Liquid CDx is a diagnostic tool that utilizes a simple blood draw to analyze over 300 genes recommended by guidelines. It is the only FDA-approved liquid biopsy that analyzes this many ā¦
Published Jan 19, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
The Guardant360 CDx test is a genomic testing option for solid cancers that has been approved by the FDA. It provides doctors with comprehensive results within a week of a simple blood draw, which ā¦
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
The cobasĀ® EBV test is a diagnostic tool used by healthcare professionals to assess the risk of infection in transplant patients. The test is designed to provide reliable, standardized, and ā¦
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
Barostim is a new therapy option for those suffering from heart failure that utilizes natural sensors in the body to regulate the heart. It is not a pacemaker or defibrillator. The therapy has been ā¦
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
The EXALT Model D is a single-use duodenoscope, which is designed to provide high performance and eliminate infection risk due to cross-contamination from ineffective reprocessing while also reducing ā¦
Published Jan 17, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
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