Other News

Amarin Reports Third Quarter 2021 Financial Results and Provides Business Update

Launched VAZKEPA in Germany with Multiple European Country Launches Expected in 2022 Introduced New Go-to-Market Strategy in U.S. to Enhance Awareness and Drive Demand for VASCEPA® Plans for Regulatory Filings and Approvals of VASCEPA in Several Additional Countries in 2022 Company to Host Conference Call Today at 7:30 a.m. ET DUBLIN, […]

Colibri Heart Valve Initiates International CE Mark-enabling Pilot Study of Second-Generation TAVI System

LOUISVILLE, CO , Nov. 03, 2021 (GLOBE NEWSWIRE) — Colibri Heart Valve LLC, a privately held emerging medical device company, today announced the initiation of an international pilot study of the Colibri transcatheter aortic valve implantation (TAVI) system. Bernard Chevalier, M.D., an interventional cardiologist at Hôpital Privé Jacques Cartier, is serving […]

Sequana Medical receives MDSAP certification and expands its Quality Management System towards North America

Ghent, Belgium – 3 November 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Single Audit Program (MDSAP) certification from its auditing organisation British Standards Institution (BSI), thereby expanding its […]

CMS Sets National Payment Rate for the HeartFlow Analysis in Doctors’ Offices and Imaging Centers

REDWOOD CITY, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced the Centers for Medicare & Medicaid Services (CMS) have established a national payment rate of $930.34 for the HeartFlow FFRct Analysis in office-based settings, such as doctors’ offices and imaging centers, […]

Zynex Celebrates 25th Anniversary

ENGLEWOOD, Colo., Nov. 3, 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 its 25th anniversary. The company was founded in 1996 by current CEO and Chairman Thomas Sandgaard in a one-bedroom […]

Stamford Health Forges New Relationship with Columbia University Irving Medical Center to Expand World-Class Heart Surgery Capabilities

STAMFORD, CT/ NOVEMBER 3, 2021— Stamford Health, known for its award-winning cardiac care through the Heart & Vascular Institute, has expanded its relationship with Columbia University to offer treatment and expertise from Columbia University Irving Medical Center’s nationally recognized heart surgeons. As a result of this new relationship, five of […]

First U.S. Patient Enrolled in Cardionomic’s CPNS Pilot Study

Study evaluates safety and performance of endovascular pulmonary nerve stimulation in ADHF MINNEAPOLIS, Nov. 2, 2021 /PRNewswire/ — Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce initial U.S. enrollment in their global Cardiac Pulmonary Nerve Stimulation (CPNS) Pilot Study (NCT04814134). The study is evaluating the safety and performance of the CPNS System […]

FDA Clears 12 New XO Cross Microcatheters

12 new hydrophilic-coated micro and support catheters cleared by FDA for broad use in the peripheral vasculature. PARK CITY, Utah, Nov. 2, 2021 /PRNewswire/ — Transit Scientific announced the FDA clearance of new hydrophilic-coated XO Cross Microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature. “The XO Cross devices […]