News | 01.17.20
Study Shows More Than Half of United States Clinical Trials Fail to Comply With Law on Reporting Results
January 17, 2020—The Lancet announced the publication of a study finding that only 41% of clinical trial results are reported promptly onto the United States trial registry, and one in three trials remain unreported.
News | 02.07.19
FDA Updates Process for Issuing Public Warnings and Notifications of Recalls
February 7, 2019—FDA Commissioner Scott Gottlieb, MD, announced new steps that the agency is taking to strengthen and modernize its process for issuing a public warning about a voluntary recall and for notification of recalls.
News | 11.26.18
FDA Announces Plans to Modernize 510(k) Program
November 26, 2018—FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH), announced proposed changes intended to modernize the 510(k) clearance pathway to keep pace with the increasing complexity of rapidly evolving technology.
News | 09.28.17
Magenta Medical Secures Funding for Development of Therapies for Acute Heart Failure
September 28, 2017—Magenta Medical, an Israel-based company developing therapeutic approaches to the management and treatment of acute heart failure, announced the closing of its $15 million Series B financing round.
News | 02.23.17
Boston Scientific Voluntarily Recalls All Lotus TAVR Devices
February 23, 2017—In a Form 8-K report to the US Securities and Exchange Commission (SEC), Boston Scientific announced a voluntary removal of all Lotus transcatheter aortic valve replacement (TAVR) devices, including Lotus with Depth Guard, from global commercial and clinical sites.
News | 10.31.16
Cardinal Health Announces Strategic Distribution Agreements in International Markets
October 31, 2016—Cardinal Health announced several new strategic distribution agreements that will enable Cordis, Cardinal Health’s interventional vascular business, to expand its product portfolio in select countries globally.
News | 09.30.16
FDA Classifies Two Field Actions Related to Medtronic's HeartWare HVAD System as Class 1 Recalls
September 30, 2016—Medtronic plc announced today that two previously communicated global voluntary recalls related to the HeartWare International HVAD system, a full-support ventricular assist device, have been classified as class 1 by the US Food and Drug Administration (FDA).
News | 09.19.16
Edwards Sapien 3 TAVR Device Receives Intermediate-Risk Indication in Europe
September 19, 2016—Edwards Lifesciences Corporation announced that it has received CE Mark approval to expand use of the Sapien 3 transcatheter aortic valve replacement (TAVR) device for the treatment of patients with severe, symptomatic aortic stenosis who are at intermediate risk for open heart surgery.
News | 08.18.16
FDA Approves Expanded Indication for Edwards' Sapien 3 TAVR Device
August 18, 2016—Edwards Lifesciences Corporation announced US Food and Drug Administration (FDA) approval to expand use of its Sapien 3 transcatheter aortic valve replacement (TAVR) device for the treatment of patients with severe, symptomatic aortic stenosis who have been determined by a heart team to be at intermediate risk for open heart surgery.
News | 08.09.16
News | 07.25.16
Safety Issues Compared for Devices First Approved in Europe Versus the United States
July 25, 2016—Medical devices first approved in the European Union are associated with an increased risk of postmarketing safety alerts and recalls compared with devices first approved in the United States, concluded Thomas J. Hwang et al in a study recently published online in the British Medical Journal (BMJ). The investigators further advised that poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment.
News | 03.14.16
Legislation Proposing Medical Device Priority Review Moves to Full Senate
March 9, 2016—Senators Orrin Hatch (R-Utah), Michael Bennet (D-Colorado), and Richard Burr (R-North Carolina) announced that the US Senate’s Health, Education, Labor, and Pensions Committee has sent the bipartisan Advancing Breakthrough Devices for Patients Act to the full Senate.