Reimbursement dossiers for first 10 countries to be filed in coming months 150 people hired and on-track to be deployed by mid-Q2 2021 supplemented by digital outreach and medical education programs with initial top priority on Germany VAZKEPA commercial launch in Germany planned for Q3 2021 DUBLIN, Ireland and BRIDGEWATER, […]
Coronary/Structural Heart
Dr. Dipti Itchhaporia is New American College of Cardiology President
Itchhaporia looks to further digital transformation and health equity in cardiology during one-year term WASHINGTON, April 1, 2021 /PRNewswire/ — Dipti Itchhaporia, MD, FACC, today begins her term as president of the American College of Cardiology. During her one-year presidency, she will lead the over 54,000-member global organization in its mission to transform […]
B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter
Following Receipt of FDA Breakthrough Device Designation, Market Leading Global Organizations Strengthen their Cooperation to Navigate U.S. Regulatory Pathway BETHLEHEM, Pa., March 31, 2021 /PRNewswire/ — B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate the U.S. Food and Drug Administration (FDA) Investigational Device Exemption […]
Lawrence Berkeley National Laboratory Introduces New Method to Monitor Endothelial Function, Aiding Prevention, Treatment of Heart Disease
Invention opens doors for medical device manufacturers to develop at-home or wearable devices to measure endothelial health BERKELEY, Calif.–(BUSINESS WIRE)–Endothelial function, like blood pressure, is a powerful predictor of heart attack and stroke; emerging studies have linked the COVID-19 virus to endothelial dysfunction. Lawrence Berkeley National Laboratory (Berkeley Lab) has […]
Randomized Clinical Trial Results Confirm PleuraFlow Reduces Take Back for Bleeding in Cardiac Surgery Patients
Reduction in chest tube clogging and take back for bleeding shown in randomized prospective clinical trial with PleuraFlow ACT System IRVINE, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Irvine, California, has announced positive clinical trial results published in the peer-reviewed Journal of Cardiothoracic Surgery. The findings are reported by cardiac […]
Zynex Recognized as the Sixth Largest Biotechnology/Bioscience Company in Colorado
ENGLEWOOD, Colo., March 30, 2021 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics today announced the Denver Business Journal has recognized Zynex as the sixth largest Biotechnology/Bioscience public company in Colorado based on number of […]
Shockwave Provides Update on U.S. Launch of Coronary IVL System
Announces Preliminary Revenue Range for the First Quarter of 2021 SANTA CLARA, Calif., March 30, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced a preliminary forecast revenue range for the first quarter […]
Devonian Health Group Announces Notice of Allowance for a US Patent Application Covering Use of Thykamine™ for the Treatment of Cardiovascular Diseases.
QUEBEC CITY–(BUSINESS WIRE)–Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD), a clinical stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent […]
Mezzion Announces Re-Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
Submitted for FDA Priority Review as a Rare Pediatric Disease Product Application SEOUL, South Korea, March 28, 2021 /PRNewswire/ — Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has re-submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of udenafil to improve the exercise capacity of patients […]
FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease
New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract SILVER SPRING, Md., March 26, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult […]
