CoreMap wins FDA IDE for ablation mapping tech
May 29, 2025
CoreMap announced that it received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S.
CoreMap announced that it received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S.
New AI-driven software delivers unprecedented image quality improvements, enhancing diagnostic accuracy and expanding the capabilities of portable MRI technology.
SAN FRANCISCO, May 29, 2025 /PRNewswire/ — Darmiyan, Inc., a leading brain health technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s post-market surveillance study for BrainSee, its groundbreaking clinical prognostic tool for Alzheimer’s disease. This 7-year study aims to further validate the safety and effectiveness of BrainSee in a socio-demographically diverse patient population across the United States. The insights gained will also support pharmaceutical companies and contract research organizations (CROs) in identifying optimal candidates for next-generation Alzheimer’s clinical trials—advancing both precision and equity in patient selection.
Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal).
Abbott said the Tendyne system addresses a significant unmet need, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired with MitraClip.
Medtronic (NYSE: MDT)+
announced today that the FDA accepted its new Nellcor technology into its STeP program.
The company said in a news release that the latest clearance marks a significant step forward in gastrointestinal (GI) motility monitoring. It offers clinicians an advanced, non-invasive tool for assessing whole-gut transit times with unmatched accuracy and patient comfort.
CENTER VALLEY, Pa., May 27, 2025 /PRNewswire/ — Olympus, a global medical technology company committed to making people’s lives healthier, safer and more fulfilling, announced today FDA 510(k) clearance of its EZ1500 series endoscopes featuring Extended Depth of Field (EDOF™) technology.
Connected monitoring device brings real-time, remote care support for pregnant patients and individuals at cardiovascular risk.
Breakthrough endovascular device advances minimally invasive arteriovenous graft creation for patients requiring hemodialysis.