The Latest Cardiac and Vascular News
Clinically driven AI platform extends physicians’ ability to prioritize patients, reduce time to treatment and improve patient outcomes SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, announced today that it has received FDA 510(k) clearance for its Rapid PE Triage & […]
First approval of a dry powder inhaler for treatment of PAH and PH-ILD DPI device represents a convenient option for administration of treprostinil therapy Commercial launch activities underway; patient availability expected in June 2022 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit […]
HOUSTON, TX / ACCESSWIRE / May 17, 2022 / VenoStent, Inc., a clinical-stage tissue engineering company developing bioabsorbable perivascular wraps to improve outcomes in the 5 million vascular surgeries performed each year, announces that The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has granted […]
PDUFA action date set for October 8, 2022 Company preparing for Q4 commercial launch, if approved BURLINGTON, Mass., May 16, 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 infused therapies, advance patient […]
Nashville, TN (May 11, 2022) – Vesalio is excited to announce the completion of patient enrollment for the CLEAR1 FDA IDE study utilizing the NeVa™ thrombectomy platform. This is an important milestone for Vesalio to complete for entering the U.S. neurovascular market to treat patients suffering from acute ischemic stroke (AIS). AIS […]
The Onyx Frontier™ drug-eluting stent offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx™ drug-eluting stent DUBLIN, May 13, 2022 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received U.S. Food and Drug Administration (FDA) approval for the Onyx […]
Heart failure patients implanted with Barostim can now receive conditional MRI scans MINNEAPOLIS, May 09, 2022 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic resonance […]
Phase 3 DiSCOVER clinical trial initiation expected by end of Q2 2022 NEWTON, Mass., May 09, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced […]
Single- and dual-lumen biomaterial catheters allow hospitals to reduce thrombosis and vascular access complications for majority of PICC applications BILLERICA, Mass., May 05, 2022 (GLOBE NEWSWIRE) — Access Vascular, Inc. (AVI) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HydroPICC® Dual-Lumen catheter. Designed […]
ECGenius Sets a New Standard for ECG Signal Detection, Interpretation and Therapy Support COPENHAGEN, Denmark , May 4, 2022 /PRNewswire/ — CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the FDA 510(k) clearance of the ECGenius EP Recording System. ECGenius, the […]
