IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA […]
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Shockwave Announces Proposed Public Offering of Common Stock
SANTA CLARA, Calif., June 16, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (“Shockwave”) (Nasdaq: SWAV) today announced it has commenced an underwritten public offering of 1,700,000 shares of its common stock. All of the shares of common stock are being offered by Shockwave. In addition, Shockwave intends to grant the […]
CardioFocus® Announces Initial Commercial Procedures Following US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation
MARLBOROUGH, Mass., June 16, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight® X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm disorder. Henry D. Huang, M.D., FACC, […]
Introducing The StopAfib.org Library Collection of No-Cost Videos for Atrial Fibrillation Patients
DALLAS, June 16, 2020 /PRNewswire/ — The StopAfib.org Library, an invaluable collection of video resources for people living with atrial fibrillation (afib), is now available at no cost. The world-renowned StopAfib.org patient advocacy organization empowers those living with afib to take control of their treatment and get their lives back. This one-stop source […]
Contego Medical Announces the Start of Enrollment in the PERFORMANCE II Carotid Stenting Clinical Trial
RALEIGH, N.C., June 15, 2020 /PRNewswire/ — Contego Medical, Inc. today announced enrollment of the first patient in the PERFORMANCE II Trial evaluating the safety and effectiveness of the Neuroguard IEP® 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat […]
Keystone Heart, A Venus Medtech Company, Acquires 510 Kardiac Devices, Inc.
TAMPA, Fla., June 16, 2020 /PRNewswire/ — Keystone Heart, LTD., a medical device innovator driven to redefine the standard of structural heart care, today announced it has acquired 510 Kardiac Devices, Inc., a privately-held medical device company and makers of the Lim Transseptal System. The Lim Transseptal System was designed to meet the demands […]
Proximo Medical and Coala Life Partner for Commercialization in Select U.S. Markets
CASTLE PINES, Colo., June 16, 2020 /PRNewswire/ — Today Proximo Medical, LLC, a business acceleration solution that addresses medical device commercialization challenges among startup and established medical device technologies looking to expand adoption in the U.S., announced a partnership with Coala Life, a leading Swedish-headquartered digital health company, in select U.S. markets. The COALA® Heart Monitor provides […]
MedAlliance Gains CE Mark Approval for Coronary SELUTION SLR™ Sirolimus Drug Eluting Balloon
MUMBAI, India, June 16, 2020 /PRNewswire/ — MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad […]
Abiomed Launches Virtual Physician Education Program, CAMP PCI, to Improve High-Risk PCI Patient Outcomes
DANVERS, Mass.–(BUSINESS WIRE)–Today, Abiomed (NASDAQ: ABMD) launches a cutting-edge digital education platform called CAMP PCI, which stands for Coronary Artery & Myocardial Protected Percutaneous Coronary Intervention, to improve patient outcomes and quality of life with supported high-risk PCI by utilizing best practices, techniques and technologies to enable safer, more effective and complete revascularization. […]
Canon Medical Receives FDA Clearance for Compressed SPEEDER Technology for 1.5T MR, Enabling Reduced Scan Times
New Software Version for Vantage Orian 1.5T Also Offers Cybersecurity Solutions to Protect Patient Data TUSTIN, Calif.–(BUSINESS WIRE)–Hospitals and institutions are continually looking for ways to improve diagnostic imaging throughput, especially in today’s environment where disinfection of systems and rooms in between patients is crucial. Now, with the newly FDA-cleared […]
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