Two-Year Feasibility Study Results Encouraging with Medtronic Harmony(TM) Transcatheter Pulmonary Valve

DUBLIN and SAN DIEGO — April 26, 2018 — Medtronic plc (NYSE: MDT) today announced two-year outcomes for the Harmony(TM) Transcatheter Pulmonary Valve (TPV) from its early feasibility study. Presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 41st Annual Scientific Sessions, data from 18 patients followed out to two years revealed the Harmony TPV showed solid valve function and no paravalvular leak (PVL).

FDA's Gottlieb: AI-based imaging device submissions expected to increase in coming years

scott gottlieb md

Former FDA commissioner Scott Gottlieb, MD

FDA Commissioner Scott Gottlieb, MD, said his administration is working on an updated “new regulatory framework” to promote the use of artificial intelligence (AI) in healthcare, and he expects medical imaging to be at the forefront of AI-based healthcare devices, according to a report published by The Hill.