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@ShahidNShah
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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
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 …
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated
The aprevo spine fusion device by Carlsmed is a product that utilizes patient data and digital technologies to create personalized surgical plans and devices for each individual patient. Carlsmed aims …
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated
The AltuMED PracticeFit is a software designed to assist healthcare providers in the financial aspect of their practice. The software conducts thorough checks on the financial eligibility of patients, …
Published Jan 20, 2023 Application Programming Interface (APIs)
Last Updated
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 …
Published Jan 19, 2023 FDA Breakthrough Device Designation
Last Updated
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