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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 Jan 24, 2023
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 Jan 24, 2023
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 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, …
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 …
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 …
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 …
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 …
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 …
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
The cobas® 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 …
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
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