The Latest Cardiac and Vascular News
The LINQ II ICM is the first continuous, long-term cardiac monitor cleared by FDA for the pediatric patient population DUBLIN, Sept. 20, 2022 /PRNewswire/ — Medtronic plc ( NYSE:MDT), a global leader in healthcare technology, today announced the LINQ II™ Insertable Cardiac Monitor (ICM) […]
Breakthrough Designation Reinforces Significant Unmet Need in Treatment of Small Vessel Coronary Arteries LOS GATOS, Calif., Sept. 19, 2022 /PRNewswire/ — Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease’s most significant challenges through the creative applications of nanotechnology, […]
TAMPA, Fla., Sept. 17, 2022 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR). US FDA’s IDE approval allows the MagicTouch SCB to be used in a pivotal clinical study to support […]
FDA Also Approves and Closes RECOVER III Post-Approval Study DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces two approvals from the U.S. Food and Drug Administration (FDA) related to clinical research of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients. […]
IRVINE, Calif., Sept. 15, 2022 /PRNewswire/ — Edwards Lifesciences Corporation ( NYSE: EW), today announced the company’s PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR). “Patients suffering with debilitating […]
HALIFAX, Nova Scotia, Sept 12, 2022 – ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces FDA 510(k) clearance of Easi-Vue embolic microspheres for the treatment of patients […]
IRVINE, Calif., Sept. 12, 2022 /PRNewswire/ — Edwards Lifesciences ( NYSE: EW) today announced the launch of the SAPIEN 3 Ultra RESILIA valve, which incorporates Edwards’ breakthrough RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The launch follows recent […]
This is the second Fast Track designation issued by the FDA for abelacimab Abelacimab is a dual-acting, once-monthly, fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity CAMBRIDGE, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) […]
US Arm of IMPACT II Study Will Ascertain Reduction of Esophageal Thermal Injury During Cardiac RF Ablation Procedures CHICAGO–(BUSINESS WIRE)–The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in […]
WATCHMAN FLX now the only LAAC technology in the United States that allows for either DAPT or OAC immediately following implantation MARLBOROUGH, Mass., Sept. 6, 2022 /PRNewswire/ — Boston Scientific Corporation ( NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the […]
