Magenta Medical initiates its Early Feasibility Study in leading NY cardiology centers KADIMA, Israel, June 7, 2023 /PRNewswire/ — Magenta Medical, developer of the world’s smallest heart pump, announced today the initiation of its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular […]
Regulatory
Teleflex Receives FDA Clearance for the Wattson® Temporary Pacing Guidewire
Company expands Structural Heart Portfolio with the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV) WAYNE, Pa., June 07, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: […]
Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System
IRVINE, Calif, June 7, 2023 /PRNewswire/ — Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retriever™ System and its Malibu Aspiration Catheter™ System for use in the peripheral vasculature. The two […]
Teleflex Announces the Arrow® EZ-IO® Needle Is Now FDA Cleared For Use in an MRI Environment
First and Only IO Needle with MR Conditional Safety Status Labeling WAYNE, Pa., June 06, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, today announced that the Arrow® EZ-IO® Needle […]
GE HealthCare Introduces Sonic DL: A Groundbreaking, FDA-Cleared AI Deep Learning Technology for Faster MRI
Sonic DLi is a deep learning (DL) technology that acquires high-quality magnetic resonance (MR) images up to 12 timesii faster than conventional methods, enabling cardiac imaging within a single heartbeat When applied to cardiac MRI, Sonic DL extends access to cardiac patients […]
FDA Clears Sparrow’s Smartphone Stethoscope For Use by Medical Professionals
Breakthrough SaaMD enables smartphones to be used as class-leading stethoscopes that capture, analyze and share cardiovascular and pulmonary sound data ST. JOHN’S, Newfoundland–(BUSINESS WIRE)–Sparrow BioAcoustics today announced it has received clearance from the U.S. Food and Drug Administration to market its […]
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways […]
Acticor Biotech: Progress in Discussions with EU and US Regulatory Agencies
The FDA has provided valuable feedback to reinforce the proposed clinical development plan of glenzocimab in acute ischemic stroke (AIS) A new Type C consultation with the FDA has been granted on the pharmaceutical development plan In Europe additional scientific […]
LEXICON ANNOUNCES FDA APPROVAL OF INPEFA™ (SOTAGLIFLOZIN) FOR TREATMENT OF HEART FAILURE
INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart […]
Medtronic AccuRhythm AI technology receives 2023 MedTech Breakthrough Award as Best New Monitoring Solution
AccuRhythm AI algorithms now cleared by FDA for the Reveal LINQ ICM; enhancements made to the AF algorithm for the LINQ II ICM DUBLIN, May 16, 2023 /PRNewswire/ — Medtronic plc (NYSE: MDT) today announced its AccuRhythm™ AI algorithm technology is the winner […]