NEW HOPE, Pa., Sept. 19, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration […]
Tag: IDE
BIOTRONIK Enrolls First Patient Into BIO-CONDUCT, First IDE Trial to Study Use of Stylet-Driven Leads for Conduction System Pacing
LAKE OSWEGO, Ore., Dec. 12, 2022 /PRNewswire/ — BIOTRONIK, a global leader in the treatment of cardiac and vascular disease is pleased to announce the first patient enrollment in BIO-CONDUCT, an FDA approved investigational device exemption (IDE) trial examining the use of […]
Endologix Receives IDE Approval For The EVAS2 Confirmatory Clinical Study To Evaluate The Nellix Endovascular Aneurysm Sealing System
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a confirmatory clinical […]
Endologix announces enrolment of first patients in ELEVATE IDE clinical study
Mar 31, 2017 – IRVINE, Calif.–(BUSINESS WIRE)– Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that the first patients were treated in the Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft […]
Aegis Medical Innovations Announces FDA Approval of Clinical Trial
VANCOUVER, British Columbia–(BUSINESS WIRE)–Aegis Medical Innovations Inc. (Aegis) today announced that it has received Investigational Device Exemption approval from the U.S. FDA to initiate a clinical trial in the U.S. for its medical device called the Sierra Ligation System (Sierra). […]