Category: HeartWare International Inc.
FDA regulators publish a formal warning against HeartWare, for which the company had advised shareholders to be on the lookout.
FDA inspectors finally revealed the anticipated warning letter against Massachusetts-based medical device maker HeartWare (NSDQ:HTWR), chiding the company for manufacturing violations.
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.
Class I recalls: 9
Class II recalls: 137
HeartWare says the FDA issued a warning letter yesterday, flagging inadequate procedures at a plant in Miami Lakes, Fla.
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.
HeartWare shares gain 11% after the medical device company beat Wall Street's expectations with its 1st quarter results.
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.
The FDA puts its highest-risk Class I label on HeartWare's recall of ventricular assist devices.
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.
Massachusetts-based HeartWare reminds doctors about an issue with its ventricular assist system that the company says "could cause serious injury or death."
HeartWare International (NSDQ:HTWR) reissued warnings today to remind doctors of serious concerns with its HeartWare Ventricular Assist System.
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 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.