Author: Ken Dropiewski

CinCor Pharma Announces Receipt of Minutes from End-of-Phase 2 Meeting with the U.S. Food and Drug Administration on Planned Phase 3 Program of Baxdrostat

WALTHAM, Mass., Feb. 21, 2023 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (“CinCor” or the “Company”) announced today completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) on the anticipated Phase 3 program for baxdrostat in hypertension. Baxdrostat is a once daily potentially first-in-class, highly selective […]

Alnylam Announces U.S. Food and Drug Administration (FDA) Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis

– PDUFA Date Set for October 8, 2023 – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the […]

Medtronic Receives CE Mark for Extravascular Defibrillator System That Treats Abnormal Heart Rhythms

EV-ICD defibrillation lead placed outside of heart and veins, preserving vasculature DUBLIN, Feb. 17, 2023 /PRNewswire/ — Medtronic plc (NYSE:MDT) has received CE (Conformité Européenne) Mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden […]

Shockwave Medical Reports Fourth Quarter and Full Year 2022 Financial Results

SANTA CLARA, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today reported financial results for the three months and full year ended December 31, 2022. Recent Highlights Recognized revenue […]

Daxor Corporation Appoints Linda Cooper, Vice President Project Management

Oak Ridge, TN, Feb. 17, 2023 (GLOBE NEWSWIRE) — Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces the appointment of Linda Cooper as Vice President of Project Management. “Linda joins Daxor with over 30 years of experience in product development and commercialization in the medical device […]

According to THE SAGE GROUP, High Restenosis Rates Following Endovascular Treatment of Infrapopliteal Disease Create a Significant Need for Improved Technologies

BEAUFORT, S.C.–(BUSINESS WIRE)–Recent research published by THE SAGE GROUP examines the challenges of infrapopliteal Peripheral Artery Disease (PAD) and incidence of restenosis. “It is difficult to reach strong conclusions regarding device superiority for endovascular treatment of infrapopliteal disease,” stated Mary L. Yost, President of THE SAGE GROUP. “This reflects limitations […]

Perfuze Announces FDA Clearance and First U.S. Clinical Use of Millipede 088 Access Catheter

Irish-based company secures first U.S. regulatory clearance for its Millipede 088 Access Catheter from the Food and Drug Administration (FDA) The company is also developing catheter-based technology for treating acute ischemic stroke GALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has secured […]

GORE INITIATES STUDY TO EVALUATE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AS BRIDGING STENT

The EMBRACE Registry aims to evaluate safety and performance of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a bridging stent with branched and fenestrated endografts in the treatment of aortic aneurysms involving the renal-mesenteric arteries. PUTZBRUNN, Germany, Feb. 16, 2023 /PRNewswire/ — W. L. Gore & Associates, Inc. (Gore) announced that it […]