The U.S. Food and Drug Administration (FDA) announced that Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) due to a defect in the manufacturing process. The FDA said this defect causes an out-of-specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.

February 26, 2018 – The American Society of Echocardiography (ASE) and its International Alliance Partners are joining ...

February 23, 2018 — Boston Scientific announced In November 2017 a delay to timelines for commercialization of the Lotus ...

NaviGate Cardiac Structures Inc. (NCSI)announced that on Feb. 2, 2018, its catheter-guided Gate valved-stent bioprosthesis became the first Canadian orthotopic valve replacement to treat severe tricuspid regurgitation. The procedure was performed at the Quebec Heart and Lung Institute, Laval University (Quebec City, Canada) by the Institute’s Cardiac Team, led by Josep Rodés-Cabau, M.D., interventional cardiologist, an internationally known expert in tricuspid disease therapy; and François Dagenais, M.D., chief of cardiac surgery at the institute. They performed the Health Canada-sanctioned Expanded Access (Compassionate Use) procedure in the patient who presented with severe symptomatic tricuspid regurgitation.

The U.S. Food and Drug Administration (FDA) issued the final rule on “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices.” The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.

Deep learning startup company Aidoc announced what it calls the world’s first and only comprehensive, full-body solution utilizing artificial intelligence (AI) to help analyze computed tomography (CT) scans, highlighting medical findings for radiologists. The workflow-integrated solution offers support for radiologists covering areas such as the head, c-spine, chest and abdomen.