The Latest Cardiac and Vascular News
FDA to Review First-of-Its-Kind Percutaneous Femoropopliteal Bypass System IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives by providing disruptive therapies for the interventional treatment of vascular disease, today announced the submission of a Premarket Approval (PMA) application requesting approval for the DETOUR System to […]
FUROSCIX demonstrated 99.6% bioavailability and produced similar diuresis and natriuresis compared to intravenous furosemide Commercial launch planned in Q1 2023 BURLINGTON, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of […]
The Company filed a 510(k) premarket notification for its prescription-only medical device to be used in-home for babies under the supervision of a physician LEHI, Utah–(BUSINESS WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”) for […]
— If 510(k) cleared, this next-generation investigational inhaled nitric oxide delivery system would be the latest in a long line of dual channel delivery systems building on Company’s dedication to meeting clinicians’ evolving needs — DUBLIN, Sept. 28, 2022 /PRNewswire/ — Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced the submission of a […]
PALO ALTO, Calif., Sept. 22, 2022 /PRNewswire/ — DyAnsys, Inc., has announced that Primary Relief, a percutaneous electrical neurostimulation device, has been approved to treat pain following a cardiac surgery. The percutaneous electrical nerve stimulator (PENS) system can be used for up to three days for symptomatic relief of post-operative pain following […]
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) system is the first-and-only ICM to receive 510(k) clearance by […]
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, today announced the U.S. Food and Drug Administration (FDA) has […]
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 safety and effectiveness of this combination product. The data generated […]
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. The FDA has approved the on-label RECOVER IV randomized controlled […]
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 symptoms as a result of degenerative mitral regurgitation represent a […]
