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.

February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commencement ...

A late-breaking analysis of the landmark COMPASS study was presented at the 2018 International Stroke Conference (ISC), showing that people with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) taking Xarelto (rivaroxaban) had fewer ischemic strokes compared to those taking aspirin alone. This analysis, which specifically examined patients from COMPASS who experienced a stroke, also found high-risk patients taking Xarelto plus aspirin had the largest reductions in stroke.