HeartWare International Inc (NASDAQ: HTWR), a developer of medical devices, confirmed on Wednesday it has received notice from Engaged Capital, an activist hedge fund and shareholder, which nominated ...

Medical technology giant Medtronic plcMDT recently completed the acquisition of HeartWare International, Inc. HTWR - a global medical device manufacturer dedicated to serve patients with advanced ...

The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after ...

The US Food and Drug Administration (FDA) is notifying physicians of a Class I recall of unimplanted HeartWare ventricular assist device (VAD) implant kits, initiated voluntarily by the company in ...

The FDA's Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage ...

The US Food and Drug Administration (FDA) is notifying physicians and hospitals of a class I recall of batteries in the HeartWare ventricular assist device (VAD), which is used in patients with ...

Privately-held Valtech Cardio, set to be acquired by HeartWare International Inc.HTWR, recently announced the receipt of CE mark approval for its Cardioband Mitral Reconstruction System. Valtech will ...

FRAMINGHAM, Mass. and SYDNEY, Australia, April 18 HeartWare Limited (ASX: HTW) today announced that it is moving to an expanded,upgraded manufacturing facility in Miami Lakes, FL, USA. The new ...

FRAMINGHAM, MA — The US Food and Drug Administration issued a formal warning to the makers of a recently approved ventricular assist device (VAD) system (HeartWare, Framingham, MA) for failing to take ...

Both the agency and its panel of advisors had been concerned about an annual 9.2% rate of pump-related thrombus observed in the nonrandomized ADVANCE trial, which compared the HeartWare device ...