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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, …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
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 …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
The i-STAT Alinity is a portable blood analyzer that uses proven technology from the i-STAT 1 System to deliver real-time, lab-quality diagnostic test results. It features an intuitive interface that …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
The IpsiHand is a device designed to assist individuals with chronic stroke in their rehabilitation. It is the first FDA-cleared device that utilizes brain-computer interface technology to improve arm …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
Harmony™ TPV is a new transcatheter valve system that has recently been granted FDA approval for the treatment of severe pulmonary regurgitation in patients with a native or surgically-repaired right …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
Canvas Dx is a software as a medical device (SaMD) that has been authorized by the FDA to aid physicians in diagnosing autism spectrum disorder (ASD) in young children. This technology utilizes …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
Paired VNS, a treatment for stroke survivors, aims to improve hand and arm function by stimulating the vagus nerve. The vagus nerve, the longest nerve in the body, is responsible for sending messages …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
The Paige Prostate Suite is a set of AI applications designed to assist pathologists in the detection and diagnosis of prostate cancer. The suite includes Paige Prostate Detect, Paige Prostate Grade …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
The ELF™ Test is a non-invasive blood test that can be performed on Atellica® IM Analyzer and ADVIA Centaur® Immunoassay systems. It measures three markers of fibrosis in the liver: hyaluronic acid …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
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 …
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated
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