Tag:
HeartWare International
Latest Headlines
Latest Headlines
HeartWare enrolls final patient in pivotal HVAD implant study
HeartWare International ($HTWR) has reached another huge milestone in developing its ventricular assist system for patients with end-stage heart failure, finishing enrollment in a pivotal U.S. clinical study testing the device as a destination therapy.
FDA panel widely supports HeartWare's LVAD
HeartWare International ($HTWR) is now wielding a crucial weapon in the company's quest to gain FDA approval for its left ventricular assist device: A panel of experts voted solidly to back the product.
FDA panel to evaluate HeartWare International's blood pump
HeartWare International's blood pump and Cameron Health's under-the-skin defibrillator go before an FDA panel of experts this week whose recommendation could make or break their chances for marketing approval.
HeartWare begins partial recall of controller
HeartWare International has initiated a voluntary field corrective action and started in-field repairs of certain controllers because a small number have exhibited reduced levels of speaker volume.
