Author: Ken Dropiewski

CathWorks FFRangio™ System Receives Regulatory Approval in Japan

KFAR-SABA, Israel and ALISO VIEJO, Calif., Dec. 11, 2019 /PRNewswire/ — CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW). The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images […]

Merit Medical launches PreludeSYNC EVO™ radial compression device in EMEA

Maastricht, The Netherlands – 11th December 2019 Merit Medical Systems Inc., a leading manufacturer of proprietary devices used primarily in cardiology, radiology, oncology, and endoscopy, announces the commercial launch of the PreludeSYNC EVO radial compression device in European, Middle Eastern and African markets. The product has FDA clearance in the […]

ELDORADO Selects AdaCore’s QGen for Critical Medical Applications

Model-based engineering toolsuite brings high reliability to medical device software NEW YORK & PARIS & CAMPINAS, Brazil–(BUSINESS WIRE)–AdaCore today announced that The ELDORADO Research Institute of Brazil (ELDORADO) has selected the QGen model-based code generation and verification toolsuite to support research and development of safety-critical medical device software. These applications […]

CORRECTING and REPLACING First Patient Enrolled in PROMISE II U.S. Pivotal Study of LimFlow System to Treat Chronic Limb-threatening Ischemia

Clinical Study to Evaluate Device’s Ability to Prevent Amputation and Promote Wound Healing in Patients with No Other Options CORRECTION…by LimFlow SA PARIS–(BUSINESS WIRE)–First paragraph, last sentence should read: The successful first case was performed by Mark Archie, MD, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, […]

InspireMD Announces Planned Leadership Transition

Life sciences industry veteran Marvin Slosman appointed Chief Executive Officer   Appointment adds significant medical technology commercialization experience to the InspireMD team TEL AVIV, Israel, Dec. 10, 2019 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused […]

Orchestra BioMed™ Secures $20 Million Financing Facility from Silicon Valley Bank

NEW YORK, Dec. 10, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced that it has entered into a $20 million credit facility agreement with Silicon Valley Bank (SVB), the bank of the world’s most […]

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 […]

Quantum Genomics and Biolab Sanus Pharmaceutical Enter into Exclusive Licensing and Collaboration Agreement for Firibastat in Latin America

Biolab Sanus Pharmaceutical to receive an exclusive license to develop and commercialize firibastat for the treatment of arterial hypertension in Latin America PARIS and NEW YORK, Dec. 09, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specializing in developing a new drug class that directly targets the […]