The Latest Cardiac and Vascular News
Amsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its response to the U.S. Food and Drug Administration’s (FDA) Letter to Health Care Providers regarding treatment of peripheral artery disease (PAD) in the superficial femoropopliteal artery (SFA) with paclitaxel-coated devices. Importantly, the FDA recommendation continues […]
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first ‘Breakthrough Device Designation’ received by Concept Medical […]
Acquisition Expands Addressable Market Opportunity and Complements Offerings for the Treatment of Atrial Fibrillation Announces Updates to 2019 Outlook Conference Call Monday, August 12th at 8:30am ET MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced that […]
OSLO, Norway, Aug. 12, 2019 /PRNewswire/ — CardioMech AS, a privately-held company developing a transcatheter mitral valve repair technology, announced today that it has closed on a convertible note financing of $5 million,significantly oversubscribed. The note included investments from experienced MedTech investors and brings the total amount raised for CardioMech to $7.5 million in 2019. Proceeds from […]
Study will evaluate a percutaneous therapy designed to improve left ventricular function for patients with systolic heart failure SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced the first patient was enrolled in the CorCinch EU study, a European multi-center clinical […]
SEATTLE, Aug. 9, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in the organization’s 2019 accelerator program. BardyDx […]
PDUFA Date Extension to End of December 2019 Expected Management to Host Conference Call Today at 7:00 p.m. ET BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today that it received notice today from the […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a new pivotal study to evaluate the safety and effectiveness of the Nellix […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced an agreement naming Boston Scientific Corporation (NYSE: BSX) the exclusive distributor for Endologix products in China. The long-term agreement includes distribution rights to Endologix’s current EndoVascular Aneurysm Repair (EVAR) and Endovascular Aneurysm […]
Confirmatory Phase 3 Study Protocol Finalized for CLBS14 in No-Option Refractory Disabling Angina Conference call begins today at 4:30 p.m. Eastern time BASKING RIDGE, N.J., Aug. 08, 2019 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a late-stage therapeutics development biopharmaceutical company pioneering advancements of cell […]
