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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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HeartWare jumps after Q1 results beat estimates

May 2, 2014 by Brad Perriello

HeartWare shares gain 11% after the medical device company beat Wall Street's expectations with its 1st quarter results.

HeartWare jumps after Q1 results beat estimates

HeartWare International (NSDQ:HTWR) shares gained more than 11% yesterday after the medical device company reported surging revenues and 1st-quarter losses that bettered analysts' forecasts.

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FDA bumps HeartWare's recall to highest-risk | MassDevice.com On Call

April 30, 2014 by Arezu Sarvestani

The FDA puts its highest-risk Class I label on HeartWare's recall of ventricular assist devices.

MassDevice.com On Call

MASSDEVICE ON CALL — The FDA this week put its highest-risk label on a recall of HeartWare International's (NSDQ:HTWR) circulatory support system over concerns about failed locking mechanisms that could leave the implants without power.

HeartWare warns again on issues with ventricular assist system

April 25, 2014 by Arezu Sarvestani

Massachusetts-based HeartWare reminds doctors about an issue with its ventricular assist system that the company says "could cause serious injury or death."

HeartWare warns again on issues with ventricular assist system

HeartWare International (NSDQ:HTWR) reissued warnings today to remind doctors of serious concerns with its HeartWare Ventricular Assist System.

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HeartWare gains on positive heart pump data

April 14, 2014 by Brad Perriello

Shares of HeartWare International gain after the medical device company reports positive results for a post-approval study of its HVAD implantable heart pump.

HeartWare gains on positive heart pump data

HeartWare International (NSDQ:HTWR) shares are up today on the medical device company's 1st release of data since its HVAD implantable heart pump went on the U.S. market.

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