Category: HeartWare International Inc.Syndicate content

LVAD slump? Thoratec dims outlook after Q3 earnings plunge

November 6, 2014 by Brad Perriello

Thoratec's 3rd-quarter earnings plunge nearly 85% as sales decline more than 16%, raising fears that the left ventricular-assist device market is in a slump that could persist into 2015.

LVAD slump? Thoratec dims outlook after Q3 earnings plunge

Thoratec (NSDQ:THOR) yesterday said its 3rd-quarter profits plunged some 85%, missing forecasts, and dimmed its outlook for the rest of the year.

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U.S. sales narrow HeartWare's Q3 losses

October 31, 2014 by Val Kennedy

HeartWare posts narrowed 3rd-quarter losses thanks to increased sales of its implantable heart pumps in the U.S.

U.S. sales narrow HeartWare's Q3 losses

HeartWare International (NSDQ:HTWR) yesterday reported narrowed 3rd-quarter losses and significantly higher revenues, boosted by a 39% jump in U.S. sales of its implantable heart pumps.

HeartWare nabs JenaValve exec Leadley for medical chief | Personnel Moves

August 12, 2014 by Brad Perriello

HeartWare International names Dr. Katrin Leadley to be its new chief medical officer following the retirement of Dr. David Hathaway.

HeartWare nabs JenaValve exec Leadley for medical chief | Personnel Moves

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Strong Q2 can't buoy HeartWare as shares sink on recall news

July 31, 2014 by Brad Perriello

A voluntary recall initiated yesterday pushes HeartWare shares down today, despite 2nd-quarter result that crushed expectations on Wall Street.

Strong Q2 can't buoy HeartWare after recall news

UPDATED July 31, 2014 with additional comment on recall.

FDA reveals HeartWare warning letter

July 2, 2014 by Arezu Sarvestani

FDA regulators publish a formal warning against HeartWare, for which the company had advised shareholders to be on the lookout.

Another FDA warning for HeartWare

FDA inspectors finally revealed the anticipated warning letter against Massachusetts-based medical device maker HeartWare (NSDQ:HTWR), chiding the company for manufacturing violations.

May 2014 medical device recalls | Regulatory news for the week of June 9, 2014

June 10, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Medical device recalls for May 2014; Diabetes: Medtronic wins CE Mark for MiniMed Duo; Diabetes: DexCom wins FDA approval for professional glucose monitor; Unique Device Identifiers: 4 tips for compliance; HeartWare reveals FDA warning letter.

Medical device recalls for May 2014

June 3, 2014 by MassDevice staff

FDA logo

May Summary
Class I recalls: 9
Class II recalls: 137

HeartWare reveals FDA warning letter

June 4, 2014 by Brad Perriello

HeartWare says the FDA issued a warning letter yesterday, flagging inadequate procedures at a plant in Miami Lakes, Fla.

HeartWare reveals FDA warning letter

HeartWare International (NSDQ:HTWR) said today that the FDA issued a warning letter yesterday over procedures at a plant in Miami Lakes, Fla.

Framingham, Mass.-based HeartWare said the warning letter flagged 4 observations logged during an inspection of the Miami Lakes facility in January.

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