The Latest Cardiac and Vascular News
TEL AVIV, Israel, June 20, 2022 /PRNewswire/ — SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS™) to treat a variety of hypertensive disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration granted IDE approval for its […]
The US Food and Drug Administration has registered Qpatch, an ECG wearable unit developed by experts from Medicalgorithmics. The FDA approval allows use of ECG readings from Qpatch in the United States. WARSAW, Poland, June 9, 2022 /PRNewswire/ — Qpatch is a state-of-the-art […]
ALISO VIEJO, Calif., June 7, 2022 /PRNewswire/ — Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the […]
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardio Flow, Inc., a medical device company and developer of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® […]
Recardio Inc., a late stage clinical-stage life science company developing regenerative therapies for cardiovascular diseases, announced that the FDA concurs with Recardio’s pivotal Heal-MI Phase 3 trial design with Dutogliptin in Acute Myocardial Infarction. SAN FRANCISCO, June 01, 2022 (GLOBE […]
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 […]
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 […]
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 […]
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 […]
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 […]
