Author: Ken Dropiewski

Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT® Outcomes Trial

Cardiovascular disease events like heart attacks, stroke and death affect millions of patients in the United States and are estimated to cost $500 billion annually Millions of high-risk patients with cardiovascular disease could benefit from this cost-effective therapy if expanded label receives FDA approval; PDUFA date is December 28 DUBLIN, […]

Amgen And The Duke Clinical Research Institute Announce Initiation Of First Large-Scale Registry To Evaluate Real-World Lipid Management And The Effectiveness Of PCSK9 Inhibitors

New Registry, cvMOBIUS, Will Assess Lipid Therapies and Five-Year Cardiovascular Outcomes in 8,500 High-Risk Patients With a Recent Atherosclerotic Cardiovascular Disease Event THOUSAND OAKS, Calif., Nov. 15, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) in collaboration with the Duke Clinical Research Institute (DCRI) today announced plans to initiate the Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 inhibitors […]

Invitae Launches Invitae Discover Research Platform on Apple Watch; First Study on Platform Will Investigate Genetic Causes of Cardiovascular Disease

–Study announced in conjunction with American Heart Association’s Scientific Sessions– –Researchers also presenting data on limitations of highly targeted screening strategies in familial hypercholesterolemia– PHILADELPHIA, Nov. 15, 2019 /PRNewswire/ — Invitae Corporation (NYSE: NVTA), a leading medical genetics company, today announced Invitae Discover, a clinical research platform that leverages biometric data available through Apple Watch to […]

Lost Money in iRhythm Technologies, Inc.?

Gibbs Law Group Investigates Potential Securities Law Violations OAKLAND, Calif.–(BUSINESS WIRE)–iRhythm Technologies, Inc. shares fell sharply after the company filed a Notification of Late Filing with the Securities and Exchange Commission (SEC) for its Quarterly Report and revealed that it has identified errors affecting prior periods. According to iRhythm, these […]

Correvio Reports Third Quarter 2019 Financial Results

NASDAQ: CORV  TSX: CORV FDA Accepts Brinavess™ New Drug Application Advisory Committee Date Set for December 10, 2019 PDUFA Date Set for December 24, 2019 Management to Host Conference Call and Webcast Today, November 14, 2019at 8:30 a.m. Eastern (5:30 a.m. Pacific) VANCOUVER, Nov. 14, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused […]

Ultromics Receives FDA Clearance for its AI-powered Decision Support System, EchoGo Core

AI automates cardiac analysis helping earlier detection of cardiovascular disease, enabling clinicians to improve patient care and outcomes OXFORD, England, Nov. 14, 2019 /PRNewswire/ — Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for […]

Cardax Reports Q3 2019 Results

– CHASE clinical trial interim review demonstrated beneficial changes in markers of cardiovascular health – Composition of matter and use patents filed to extend U.S. and worldwide patent coverage to 2039-2040 – ZanthoSyn® sales rebounded — Q3 2019 sales five times Q2 2019, with return to normal inventory sell-in patterns […]

BioSig Technologies Issues November 2019 Shareholder Letter

Highlights include PURE EP™ System commercialization plans for 2020, clinical trial and installation updates on PURE EP™ System and other business development advancements Westport, CT, Nov. 14, 2019 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing […]

Stereotaxis Reports 2019 Third Quarter Financial Results

ST. LOUIS, Nov. 14, 2019 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, today reported financial results for the third quarter ended September 30, 2019. “The third quarter was highlighted by successful reengagement with the capital markets, meaningful progress in our […]