Category: FDA

“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow™ by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT scan all the way to the interventional suite,” said Karim Karti, CEO of RapidAI. “Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of U.S. stroke patients.”

Recognized by healthcare professionals for its user-friendly design which can improve testing compliance, POGO Automatic is endorsed as the ideal solution for many diabetes patients by Rosemarie Lajara, MD, an endocrinologist with Southern Endocrinology & Diabetes Associates, P.A. in Plano, Texas

Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.

"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."

"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."

SetPoint Medical notes acceptance into the TAP Pilot will help expedite regulatory and patient access pathways for a first-of-its-kind therapeutic approach for people with relapsing-remitting multiple sclerosis.TAP Pilot acceptance follows Breakthrough Device Designation announcement for the treatment of RRMS.