Author: Ken Dropiewski

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 […]

Zynex Announces 126% Order Growth and Increases Q1 and Full-Year Revenue Estimates

ENGLEWOOD, Colo., April 7, 2020 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in manufacturing and selling non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today announced orders and an increased revenue estimate for Q1 and the full year 2020. Orders in the first quarter […]

Rapid Medical Announces Ahead of Schedule Completion of Patient Enrollment for the TIGER Clinical Study for TIGERTRIEVER Thrombectomy Device

YOKNEAM, Israel, April 7, 2020 /PRNewswire/ — Rapid Medical, a company focused on the development of next generation neurovascular interventional devices, has announced that it has completed enrollment in the TIGER (Treatment with Intent to Generate Reperfusion) study ahead of the planned scheduled. This is a US based, multi-center study of the performance of TIGERTRIEVER, the company’s […]

Quantum Genomics Provides Update on the Impact of the COVID-19 Health Crisis on Clinical Research Activities

PARIS and NEW YORK, April 07, 2020 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat difficult-to-treat and resistant hypertension and heart failure, has released an update on how the current COVID-19 […]

Biotricity’s Real-Time Monitoring Bioflux Device can Help Identify Life Threatening QT Prolongation in COVID-19 Patients

REDWOOD CITY, Calif., April 07, 2020 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company, today announced that its Bioflux® units are designed for QT interval analysis, a section of the ECG, to identify serious risks like QT prolongation. QT prolongation is a measure of delayed ventricular repolarization, […]

McDermott + Bull Places Vice President of Clinical Affairs, Adagio Medical, Inc.

by Tori Leets | Apr 6, 2020 | Ken Dropiewski, Placement Announcement McDermott + Bull has successfully placed Richard Van Bibber as the Vice President of Clinical Affairs at Adagio Medical, Inc. He will be charged with overseeing and managing the company’s sponsored global pre-market and post-market clinical studies and is currently driving the enrollment and […]

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 […]