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Given Imaging

Medtronic wins expanded indication for Pillcam Colon 2

March 31, 2016 By Brad Perriello

Medtronic (NYSE:MDT) said today that the FDA granted an expanded indication for the Pillcam Colon 2 device it acquired along with Covidien last year. The new indication covers the detection of colon polyps in patients with bleeding in the lower gastrointestinal tract who’s health is at risk from colonoscopy or mild sedation, but could tolerate them if […]

Filed Under: Endoscopic, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Given Imaging, Medtronic

Ex-Insulet CFO Roberts lands at Avedro | Personnel Moves

January 23, 2015 By Brad Perriello Leave a Comment

Ex-Insulet CFO Roberts lands at Avedro | Personnel Moves

Filed Under: News Well Tagged With: ACell, AtriCure Inc., Avedro Inc., Avinger, Check-Cap, Covidien, Given Imaging, Hologic, Insulet, Invacare, Nextremity Solutions, OCTANe, OrthoPediatrics Corp., Personnel Moves, Repro-Med Systems Inc., Zimmer Biomet

PillCam capsule gains lower-risk classification from FDA | Medtech regulatory news for the week of May 19, 2014

May 20, 2014 By MassDevice Leave a Comment

FDA downgrades Given Imaging's PillCam

May 16, 2014 by Arezu Sarvestani

FDA downgrades Given Imaging's PillCam

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Covidien, Given Imaging

FDA downgrades Given Imaging’s PillCam

May 16, 2014 By Arezu Sarvestani

FDA downgrades Given Imaging's PillCam

Covidien (NYSE:COV) subsidiary Given Imaging landed a victory with FDA medical device regulators who agreed to downgrade the PillCam capsule endoscope to a lower-risk classification.

Filed Under: Endoscopic, Food & Drug Administration (FDA), Imaging, News Well, Regulatory/Compliance Tagged With: Covidien, Given Imaging

Apple hints at medical device app as they hire more medical sensor experts | Medtech personnel moves for the week of May 5, 2014

May 7, 2014 By MassDevice Leave a Comment

mHealth: Apple collects more medtech experts

May 5, 2014 by Arezu Sarvestani

mHealth: Apple collects more medtech experts

Filed Under: News Well Tagged With: Alphatec, American Medical Systems Holdings Inc., Apple, Cercacor, Elekta, endogastricsolutions, Given Imaging, Hansen Medical Inc., Masimo, Orthofix, Personnel Moves, Teleflex

Orthofix taps ex-AMS finance chief Heggestad to be new CFO

May 5, 2014 By Brad Perriello Leave a Comment

Orthofix taps ex-AMS finance chief Heggestad to be new CFO

Orthofix (NSDQ:OFIX) named the former CFO for American Medical Systems, Mark Heggestad, to be its new finance chief.

Filed Under: News Well, Orthopedics Tagged With: Alphatec, American Medical Systems Holdings Inc., Elekta, endogastricsolutions, Given Imaging, Orthofix, Personnel Moves

Covidien closes $860M Given Imaging buy

February 27, 2014 By Brad Perriello

Covidien closes $860M Given Imaging buy

Covidien (NYSE:COV) said it closed the buyout of Given Imaging and its PillCam imaging device for about $860 million, net of cash and investments.

Filed Under: Endoscopic, Imaging, Mergers & Acquisitions, News Well, Wall Street Beat Tagged With: Covidien, Given Imaging

Given Imaging’s PillCam Colon wins FDA clearance

February 4, 2014 By Chris Walker

Given Imaging's PillCam Colon wins FDA clearance

Given Imaging (NSDQ:GIVN) said it won 510(k) clearance from the FDA for its PillCam Colon, a modified version of its PillCam device.

Filed Under: Imaging, News Well, Regulatory/Compliance Tagged With: Colonoscopy, Covidien, Given Imaging

Medtech M&A: Covidien’s $860M buyout sends Given Imaging’s stock soaring

December 9, 2013 By Arezu Sarvestani

Medtech M&A: Covidien's $860M buyout sends Given Imaging's stock soaring

Filed Under: Diagnostics, Imaging, Mergers & Acquisitions, News Well, Wall Street Beat Tagged With: Covidien, Gastrointestinal, Given Imaging

Next-gen PillCam SB lands approval from Japanese regulators

September 24, 2013 By Arezu Sarvestani Leave a Comment

Next-gen PillCam lands approval from Japanese regulators

Israel-based Given Imaging is on a roll, landing Japanese regulatory approval for its 3rd-generation PillCam technology, a swallow-able camera designed to help diagnose gastrointestinal disease.

Filed Under: Emerging Markets, News Well, Regulatory/Compliance Tagged With: Gastrointestinal, Given Imaging

FDA win for Given Imaging’s 3rd-gen PillCam

August 13, 2013 By Sony Salzman

FDA win for Given Imaging's 3rd-gen PillCam

Israel-based Given Imaging is slated to roll out its next-generation PillCam, a capsule-sized camera device used to monitor various GI diseases, after winning 510(k) clearance from the FDA.

Filed Under: Food & Drug Administration (FDA), Imaging, News Well, Regulatory/Compliance Tagged With: Colonoscopy, Given Imaging

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