Regulatory

Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension

Sotatercept granted first FDA Breakthrough Therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the […]

Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension

RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) — Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary PRINT® technology, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application […]

Nitiloop’s NovaCross Earns FDA Clearance for Treating Chronic Total Occlusion (CTO) Prior to PTCA or Stent Intervention

Designed solely for antegrade approach, NovaCross™ is positioned to tap into the $500M CTO market, a market with only few players PARDES HANA, Israel, April 7, 2020 /PRNewswire/ — Nitiloop Ltd. to announce that it has received a 510(k) clearance from the U.S. Food & Drug Administration for its NovaCross™ CTO Microcatheter. The NovaCross™ CTO Microcatheter […]

MERIT MEDICAL RECEIVES TWO ADDITIONAL FDA BREAKTHROUGH DEVICE DESIGNATIONS

SOUTH JORDAN, Utah, April 06, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted two additional Breakthrough Device designations […]

MediLynx Cardiac Monitoring, LLC introduces dedicated remote monitoring services based on its PocketECG® platform to support hospitals in managing COVID-19 patients in accordance with the latest FDA enforcement policy

PocketECG, MediLynx’s FDA approved remote monitoring systems: PocketECG Unified Arrhythmia Diagnostic System will be used for continuous streaming and analysis of full-disclosure ECG data, oxygen saturation, resting heart rate, patient symptoms and arrhythmia. The device is cleared by the FDA for the use of its data to analyze, measure and […]

FDA Approves Next-Generation ZOLL® TherOx System for Widowmaker Heart Attack Patients

First and Only Treatment to Reduce Heart Muscle Damage Following Angioplasty and Stenting CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced today it has received U.S. Food and Drug Administration (FDA) approval of the second-generation TherOx System, which provides SuperSaturated […]

Canon Medical Receives FDA Clearance for Compressed SPEEDER Technology for 3T MR System

New Technology on the Vantage Galan 3T Can Help Clinicians Reduce Scan Times TUSTIN, Calif.–(BUSINESS WIRE)–Physicians can now scan faster with the newly FDA-cleared Compressed SPEEDER technology from Canon Medical Systems USA, Inc. Available on the Vantage Galan 3T MR system, Compressed SPEEDER technology speeds up MRI scan times by reconstructing full resolution images […]

Canon Medical’s 3T MR System Receives FDA Clearance for Artificial Intelligence-Based Image Reconstruction Technology

Vantage Galan 3T the First System in the MR Portfolio with Access to Advanced intelligent Clear-IQ Engine (AiCE) TUSTIN, Calif.–(BUSINESS WIRE)–Canon Medical Systems USA, Inc. has received 510(k) clearance on its Advanced intelligent Clear-IQ Engine (AiCE) for the Vantage Galan 3T MR system, further expanding access to its new Deep Learning Reconstruction (DLR) […]

Endologix Receives FDA Approval for Alto Abdominal Stent Graft System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the Alto™ Abdominal Stent Graft System (Alto). The Company received approval based on its […]

SynCardia Systems, LLC. 50cc temporary Total Artificial Heart (TAH-t) Now FDA Approved

TUCSON, AZ, March 09, 2020 (GLOBE NEWSWIRE) — With the FDA approval of the SynCardia Systems, LLC 50cc TAH-t system a greater number of cardiac transplant eligible patients at risk of imminent death from biventricular failure now have access to total artificial heart therapy. The 50cc TAH-t is 37.5% smaller […]