Other News

Miracor Medical Granted FDA Breakthrough Device Designation for the PiCSO Impulse System

AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases […]

BioCardia Reports 2019 Second Quarter Financial Results and Business Highlights

SAN CARLOS, Calif., Aug. 21, 2019 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the second quarter 2019 and filed its quarterly report on Form 10-Q for the three and six months ended […]

MyoKardia Begins Dosing in Phase 1 Clinical Study of MYK-224 for Hypertrophic Cardiomyopathy

SOUTH SAN FRANCISCO, Calif., Aug. 21, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced that it has dosed the first subjects in a Phase 1 clinical study of MYK-224, a small molecule candidate being developed for the treatment of hypertrophic cardiomyopathy (HCM). HCM is a progressive disease in which […]

Terason Partners With DiA Imaging Analysis to Bring Superior AI Cardiac Solutions to Point-of-care Ultrasound

BURLINGTON, Massachusetts and BE’ER SHEVA, Israel, Aug. 20, 2019 /PRNewswire/ — Terason, a leading global ultrasound imaging company based in Burlington, Mass., has partnered with DiA Imaging Analysis, a leading provider of Artificial Intelligence (AI)-based solutions for ultrasound analysis, to provide its cardiac solutions on Terason’s point-of-care ultrasound devices. The partnership fills a market need for […]

FARXIGA Met Primary Endpoint in Landmark Phase III DAPA-HF Trial for the Treatment of Patients With Heart Failure

DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor in patients with and without type 2 diabetes FARXIGA significantly reduced the risk of cardiovascular death or worsening of heart failure when added to standard of care WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive results from the landmark Phase […]

Adagio Medical Announces US FDA Investigational Device Exemption Approval With Conditions To Conduct A Clinical Study For Treatment Of Persistent Atrial Fibrillation Using The Ultra-Low Temperature Cryoablation System

LAGUNA HILLS, Calif., Aug. 19, 2019 /PRNewswire/ — Adagio Medical, Inc. (Adagio), the developer of iCLAS™, the company’s ultra-low temperature intelligent continuous lesion ablation system, announced that it has received an Investigational Device Exemption approval with conditions from the US Food and Drug Administration (FDA) to conduct a non-randomized, single-arm clinical study for persistent atrial […]

Merit Medical Announces Appointment of Lynne N. Ward to Its Board of Directors

SOUTH JORDAN, Utah, Aug. 19, 2019 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has appointed Lynne N. Ward to […]

Bardy Diagnostics™ Selected As Finalist For Two MedTech Insight Awards To Be Announced At AdvaMed’s Annual MedTech Conference

SEATTLE, Aug. 19, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that Informa Pharma Intelligence, a leading international healthcare intelligence consultancy, has recognized BardyDx as a finalist in two categories for the 2nd Annual Medtech Insight Awards for “Best Technical Innovation: Diagnostics” and “Best Proof-of-Value of an […]