The Latest Cardiac and Vascular News
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 wearable device for measuring individual ECG signal to obtain accurate […]
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 LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to 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® Peripheral Guidewire. The FreedomFlow guidewire is stainless steel core-to-tip design […]
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 NEWSWIRE) — Recardio’s Phase 2 trial results demonstrated the excellent […]
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 & […]
