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March 18, 2013
09:11 EDTNUVANuVasive says received FDA warning letter related to San Diego facility
On March 13, NuVasive received a warning letter dated March 12 from the FDA related to an inspection of the company’s San Diego, California facility that occurred from October 29, 2012 through November 2, 2012. The inspection did not result in any 483 observations and the warning letter does not cite any quality system concerns.The FDA letter identifies specific labeling claims related to the company’s ILIF procedure, indicating that one of the indications noted is not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s. The letter only relates to this promotional claim and the company does not anticipate a disruption in the distribution of these products. The company takes this matter seriously and has already begun to respond to the FDA’s requests. The company is giving the matter the highest priority in order to fully address the FDA’s concerns to our mutual satisfaction. As this is an administrative process to address the warning letter, the company believes the FDA’s concerns can be resolved without an impact on the company’s financial results or operations. Comments taken from an 8-K filing.
News For NUVA From The Last 14 Days
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April 1, 2015
15:39 EDTNUVANuVasive CEO departure increases likelihood of acquisition, says Brean Capital
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12:49 EDTNUVANuVasive culture change a positive, says Wells Fargo
Wells Fargo expects a change to NuVasive's culture with the resignation of CEO Alex Lukianov resignation and COO Keith Valentine's recent departure. Wells says that while some near-term disruption is possible, it views the change as positive since the company is transitioning from a small spine player to the number three spine company in the world. The firm keeps an Outperform rating on the name.
10:16 EDTNUVANuVasive news should not hurt ability to hit guidance, says Piper Jaffray
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08:37 EDTNUVANuVasive sees Q1 revenue exceeding $190M, consensus $189.32M
NuVasive announced that it anticipates Q1 revenue will be in excess of $190M, including more than $2M of currency headwinds, and remains on track for 2015 profitability goals. The company will announce complete financial and operating results on Q1 performance and review its guidance for FY15 when it reports Q1 results.
08:34 EDTNUVANuVasive CEO steps down, Gregory Lucier appointed chairman, interim CEO
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March 24, 2015
07:34 EDTNUVACanaccord to hold a conference
Musculoskeletal Conference is being held in Las Vegas on March 24.

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