The Latest Cardiac and Vascular News
Cardiovalve becomes first privately held company to receive FDA’s early feasibility study (EFS) approval for both tricuspid regurgitation (TR) and mitral regurgitation (MR) indications OR YEHUDA, Israel–(BUSINESS WIRE)–Cardiovalve announced today that it has received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study (EFS) of its Transcatheter Tricuspid Valve […]
SOUTH JORDAN, Utah, Feb. 20, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced today that regulatory clearances have been issued with respect to four products Merit owns or holds the rights […]
Spectral CT with Advanced intelligent Clear-IQ Engine (AiCE) Empowers Physicians with Deep Intelligence to Enable Routine Confident Diagnoses TUSTIN, Calif.–(BUSINESS WIRE)–Canon Medical Systems USA, Inc. has received 510(k) clearance for the Aquilion ONE / PRISM Edition, enabling Deep Learning Spectral capabilities that allow for more routine spectral imaging. Designed for deep […]
Breakthrough Technology Enables Super-Fast Electrical Mapping and Re-Mapping of the Entire Heart Chamber – Leading to Rapid, Efficient and Individualized Ablation Strategies CARLSBAD, Calif., Feb. 18, 2020 /PRNewswire/ — Acutus Medical today announced FDA clearance and CE Mark of SuperMap – a revolutionary addition to its AcQMap 3D Imaging and Mapping System. SuperMap is […]
RIST Cath device enables a radial approach during neurointerventional procedures for introduction of devices into the neurovasculature MIAMI BEACH, Fla.–(BUSINESS WIRE)–RIST Neurovascular, Inc., a neuro-interventional medtech company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the RIST Cath Radial Access Long Sheath™ (RIST […]
First device to reliably and repeatedly achieve central venous access from the inside-out in patients with venous obstructions SAN ANTONIO, Feb. 11, 2020 /PRNewswire/ — Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the U.S. Food and Drug […]
ATLANTA, Feb. 7, 2020 /PRNewswire/ — CorMatrix®Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced receiving FDA approval to expand and enroll 20 additional patients in the adult arm, including up to 4 additional cardiac surgery research and investigative centers, for its early feasibility IDE study of the Cor® TRICUSPID ECM® valve* for […]
SAINT PAUL, Minn.–(BUSINESS WIRE)–Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The Breakthrough Devices Program (BDP) is intended to […]
CARMAT has responded to all remaining questions from the conditional approval Number of subjects to be enrolled in the study extended to 10 patients PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for […]
ABBOTT PARK, Ill., Feb. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Implantable Left Ventricular Assist System (FILVAS). The FDA launched the Breakthrough Devices Program in 2018 to help expedite the development and review […]
