The Latest Cardiac and Vascular News
Built on the market-leading IN.PACT™ Admiral™ DCB technology, the IN.PACT™ 018 DCB is engineered to cross tight lesions and designed for better deliverability§ Medtronic today announced approval from the U.S. Food and Drug Administration (FDA) for the IN.PACT™ 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, a drug coated balloon […]
SEOUL, South Korea and BETHESDA, Md. , May 31, 2022 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart disease (SVHD) in […]
The ŌNŌ is intended to simplify bailout procedures in the expanding world of structural heart disease interventions PHILADELPHIA, May 25, 2022 (GLOBE NEWSWIRE) — ŌNŌCOR LLC, a leader in endovascular safety technology, today announced it has received 510(k) U.S. Food and Drug Administration (FDA) clearance for its ŌNŌ retrieval system, […]
Developed in collaboration with Janssen and Mayo Clinic, this technology has the potential to aid physicians in earlier detection of pulmonary hypertension, a progressive, life-threatening disease CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device […]
System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions CAMBRIDGE, Mass. and BORDEAUX, France, May 24, 2022 /PRNewswire/ — inHEART, a privately-held medical device company delivering the world’s most sophisticated digital twin of the heart, announced today that it has received FDA 510(k) clearance […]
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 […]
