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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Transforming Tricuspid Valve Care: FDA Gives Green Light to Abbott’s TriClip™
"The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker."
HeadaTerm 2: The Most Affordable FDA Cleared Innovative OTC Anti-Migraine Device
This make it one of the only wearable OTC anti-migraine device that is available without a prescription in the U.S.
Cutting-Edge Nanodrop Device Granted FDA Clearance for At-Home Blood Tests
NanoDrop has received clearance in the United States as the inaugural blood-lancing device available for over-the-counter use on the upper arm. This development is poised to revolutionize the consumer testing market and decentralized clinical trials within the realm of at-home healthcare.
Cutting-Edge Breakthrough: LB-P8 Granted FDA Fast Track for Primary Sclerosing Cholangitis
"Receiving Fast Track designation is a significant milestone in addressing the high unmet medical need for PSC, and it will facilitate the efficient development of LB-P8 by enabling close communication with the regulatory authority," said Jiyoung Ahn, Head of Clinical Development, LISCure. "By having enhanced communication with the regulatory authority, we will expeditiously bring forward a novel therapy option in an area with limited available treatments."