AdventHealth Orlando performs their first implant of Guardian™ System, revolutionizing cardiac care in Central Florida EATONTOWN, N.J. and ORLANDO, Fla., June 13, 2023 (GLOBE NEWSWIRE) — Avertix Medical, Inc. (“Avertix” or the “Company”), formerly known as Angel Medical Systems, Inc., a company focused on improving long-term management and outcomes of high-risk coronary […]
Regulatory
Rocket Pharmaceuticals Receives FDA Fast Track and Orphan Drug Designations for RP-A601 Gene Therapy for PKP2 Arrhythmogenic Cardiomyopathy (ACM)
CRANBURY, N.J.–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to RP-A601, the Company’s gene […]
Endologix Receives FDA Approval of the DETOUR™ System to Treat Long Complex Superficial Femoropopliteal Lesions in Patients with PAD
IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). Over […]
First Patients Treated in the US with the World’s Smallest Heart Pump
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 Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) […]
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: TFX), a leading global provider of medical technologies, today announced […]
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 new devices are collectively known as the Laguna Thrombectomy System. […]
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 is the first and only Intraosseous (IO) Needle to receive […]
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 with arrhythmias and breath-holding challenges, helping to ensure swift, consistent, […]
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 software that allows smartphones to be used as medical stethoscopes. […]
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 RARITAN, N.J., May 30, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson […]



