The Latest Cardiac and Vascular News
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market approvals (PMA) for Impella heart pumps. The FDA’s action is another affirmation that Impella heart pumps are safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic […]
HeartFlow is the first and only company to provide non-invasive anatomy, physiology, and plaque information based on coronary computed tomography angiography (CCTA) MOUNTAIN VIEW, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, has received U.S. Food and Drug Administration (FDA) 510(k) clearance on […]
Smaller Sheath Simplifies Access and Improves Ease-of-Use DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement of Impella CP, the new sheath maintains the same inner […]
Medtronic “conduction system pacing” expanded indication now includes left bundle branch area pacing in addition to His-Bundle pacing for patients with slow heart rates DUBLIN, Oct. 17, 2022 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for […]
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 […]
