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 […]
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PillCam capsule gains lower-risk classification from FDA | Medtech regulatory news for the week of May 19, 2014
FDA downgrades Given Imaging’s PillCam
Apple hints at medical device app as they hire more medical sensor experts | Medtech personnel moves for the week of May 5, 2014
Orthofix taps ex-AMS finance chief Heggestad to be new CFO
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.
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.
Medtech M&A: Covidien’s $860M buyout sends Given Imaging’s stock soaring
Next-gen PillCam SB 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.
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.
