Regulatory

Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events

NASDAQ: CORV TSX: CORV VANCOUVER, Dec. 24, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Brinavess™ (vernakalant IV), an anti-arrhythmic […]

FDA Grants ‘Breakthrough’ Designation to Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure

Developed in collaboration with Mayo Clinic, the algorithm would help healthcare providers detect heart failure during a standard physical exam San Francisco, CA, Dec. 18, 2019 (GLOBE NEWSWIRE) — Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, today announced the U.S. Food and Drug Administration […]

TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure

NANJING, China, Dec. 16, 2019 /PRNewswire/ — TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for TT-00920, a novel small molecule inhibitor of Phosphodiesterase 9 (PDE 9) for the treatment of chronic heart failure. […]

First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial; Study Aims to Further Demonstrate Impella’s Safety and Effectiveness

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce infarct size after a heart attack and lead to […]

FDA Clears Two Siemens Healthineers CT Systems Dedicated for Radiation Therapy Planning

• SOMATOM go.Sim and SOMATOM go.Open Pro help customers meet challenges in RT treatment planning The U.S. Food and Drug Administration (FDA) has cleared the SOMATOM go.Sim and SOMATOM go.Open Pro – two computed tomography (CT) systems from Siemens Healthineers that are dedicated for radiation therapy (RT) planning. The 64-slice SOMATOM […]

Correvio Stock Trading Halted Today; FDA Advisory Committee Meeting To Discuss Brinavess™ For Recent Onset Atrial Fibrillation

NASDAQ: CORV   TSX: CORV VANCOUVER, Dec. 10, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that NASDAQ and the Toronto Stock Exchange (TSX) have halted trading of the Company’s common stock.  The U.S. Food and Drug Administration (FDA)’s Cardiovascular and Renal […]

Bracco Diagnostics Inc.’s LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use, receives U.S. Food and Drug Administration approval for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in pediatric patients with suboptimal echocardiograms

MONROE TOWNSHIP, N.J., Dec. 2, 2019 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world’s leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is the first ultrasound enhancing agent (UEA) to obtain U.S. Food and Drug Administration (FDA) approval for […]

FDA Clears Siemens Healthineers SOMATOM X.cite CT Scanner With Intelligent User Interface Concept

myExam Companion intelligent user interface concept guides technologists through complex clinical tasks myExam Companion automatically adapts scans based on A.I.-trained clinical decision trees to simplify image acquisition parameters and reconstruction tasks SOMATOM X.cite improves patient comfort with an 82cm gantry bore and delivers powerful performance with Vectron tube MALVERN, Pa.–(BUSINESS […]

Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions

Clinical Data Demonstrates IN.PACT™ AV DCB Is Safe, Reduces Reinterventions, and Maintains Access for End-Stage Renal Disease Patients Undergoing Dialysis DUBLIN, Nov. 21, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the […]

Merit Medical Receives FDA Breakthrough Device Designation for WRAPSODY™ Endovascular Stent Graft System

SOUTH JORDAN, Utah, Nov. 21, 2019 (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 Breakthrough Device Designation […]