Category: HeartWare International Inc.Syndicate content

HeartWare recalls HVAD pump repair kit

May 18, 2015 by Fink Densford

HeartWare International issues a Class I recall for pump driveline splice kits used with its left ventricular assist device.

HeartWare recalls HVAD pump repair kit

A tale of 2 LVADs: Thoratec gains, HeartWare slides on Q1 results

May 11, 2015 by Brad Perriello

Shares of Thoratec rise after the heart pump maker beats Wall Street's forecast with its 1st-quarter results, but arch-rival HeartWare slides after just meeting The Street's bottom line.

A tale of 2 LVADs: Thoratec gains, HeartWare slideson Q1 results

LVADs: Thoratec study a Roadmap to lower-risk patients?

April 20, 2015 by Brad Perriello

Results from Thoratec's Roadmap study of its HeartMate II implantable heart pump in less-sick heart failure patients shows significant benefit over optimal medical therapy alone.

LVADs: Thoratec study a Roadmap to lower-risk patients

HeartWare slides on stroke results from heart pump studies

April 16, 2015 by Brad Perriello

Higher-than-expected stroke rates reported in a pair of studies of HeartWare's implantable heart pump this week spook investors, pushing HTWR share prices down more than 8%.

HeartWare slides on stroke results from heart pump studies

FDA finalizes fast track for devices | Regulatory news for the week of April 13, 2015

April 14, 2015 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: FDA finalizes fast-track approval for medical devices; CardiAQ Valve wins FDA nod for mitral valve trial; HemCon enters Chinese wound care market; HeartWare wins Health Canada nod for BTT heart pump; Another FDA warning letter for Hospira

FDA finalizes fast-track approval for medical devices

April 9, 2015 by Brad Perriello

HeartWare wins Health Canada nod for BTT heart pump

April 9, 2015 by Mark Hollmer

Canadian regulators approved HeartWare International's ventricular assist device as a bridge to heart transplant for patients with end-stage heart failure.

HeartWare wins Health Canada nod for BTT heart pump

HeartWare issues urgent recall for heart-pump controllers

February 23, 2015 by Val Kennedy

HeartWare International has issued an urgent recall for certain computerized controllers for its ventricular assist devices over concerns that they may malfunction and cause the heart pump to stop.

U.S. sales narrow HeartWare's Q3 losses

HeartWare International (NSDQ:HTWR) has issued an urgent recall for certain computerized controllers for its ventricular assist devices over concerns that they may malfunction and cause the heart pump to stop.