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FDA green lights Stimwave's mini spinal cord stimulator | Regulatory news for the week of December 8, 2014

December 9, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: FDA gives the green light to Stimwave's mini spinal cord stimulator; HeartFlow wins FDA OK for non-invasive FFR system; FDA warns AngioDynamics subsidiary Navilyst on hairs in PICC packaging; Philips defib updates spur ConMed electrode recall; FDA approves J&J spinal device for rare pediatric syndrome

FDA gives the green light to Stimwave's mini spinal cord stimulator

December 3, 2014 by Mark Hollmer

FDA warns AngioDynamics subsidiary Navilyst on hairs in PICC packaging

December 2, 2014 by Mark Hollmer

The FDA issues a warning letter to AngioDynamics subsidiary Navilyst Medical Systems on reports that some of its catheters shipped with hairs in their packaging.

FDA warns AngioDynamics subsidiary Navilyst on hairs in PICC packaging

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AngioDynamics revises results, ups guidance

October 10, 2014 by Alexander Soule

AngioDynamics revises its financial results back to the beginning of its 2012 fiscal year, saying it's still assessing its internal controls while getting improved visibility from a new ERP platform.

AngioDynamics restates results, ups guidance

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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AngioDynamics taps Concert Medical president Donnelly as chairman

April 29, 2014 by Brad Perriello

AngioDynamics names Concert Medical president Howard Donnelly as chairman, replacing Vincent Bucci, who stepped down last month.

AngioDynamics taps Concert Medical president Donnelly as chairman

AngioDynamics (NSDQ:ANGO) said today that it tapped Concert Medical president Howard Donnelly to replace outgoing chairman Vincent Bucci.

Bucci, 1st named to the AngioDynamics board in 2007, was named chairman later that year. He stepped down in March.

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AngioDynamics swings to Q3 black, beats The Street

April 14, 2014 by Brad Perriello

AngioDynamics reports a profitable fiscal 3rd quarter and nearly doubles Wall Street's earnings forecast, but shares slide anyway.

AngioDynamics swings to Q3 black, beats The Street

AngioDynamics (NSDQ:ANGO) put some black ink in the ledger during its fiscal 3rd quarter and handily topped Wall Street's earnings forecast, but investors have remained unmoved, sending ANGO shares down 12% since its April 9 earnings release.

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Biolitec slapped with $75M judgment in AngioDynamics suit

March 20, 2014 by Brad Perriello

AngioDynamics wins a nearly $75 million judgment against erstwhile partner Biolitec AG over an alleged scheme to evade U.S legal jurisdiction.

Biolitec slapped with $75M judgment in AnioDynamics suit

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