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Imaging

Covidien lands FDA OK for camera-equipped feeding tube

April 18, 2014 by Arezu Sarvestani

Covidien touts FDA clearance for its novel camera-equipped Kangaroo feeding tube designed to provide visualization for an otherwise blind procedure.

Covidien lands FDA OK for camera-equipped feeding tube

Medtech titan Covidien (NYSE:COV) received FDA clearance for its visual Kangaroo feeding tube, equipped with an endoscopic camera that allows physicians to see into the procedure in a new way.

Philips takes down Ohio manufacturing following inspection

April 17, 2014 by Arezu Sarvestani

Philips voluntarily suspends manufacturing at an Ohio facility after an FDA investigation turns up "certain issues in the general area of manufacturing process controls."

Philips takes down Ohio PET/CT manufacturing following inspection

Philips Healthcare (NYSE:PHG) halted work at an Ohio manufacturing facility after an FDA inspection turned up some concerns with process controls, a company spokesman confirmed with MassDevice.com today.

GE Healthcare's Q1 sales, profits slide

April 17, 2014 by Brad Perriello

Sales and profits were down during the 1st quarter for GE Healthcare, which cited "market volatility" for the declines.

keys: ge healthcare, general electric, earnings

GE Healthcare's Q1 sales, profits slide

GE Healthcare (NYSE:GE) saw its sales and profits decline by single digits during the 1st quarter due to "market volatility.

GE Healthcare lands FDA nod for all-in-one CT

April 15, 2014 by Arezu Sarvestani

FDA regulators GE Healthcare's latest high-def, low-dose CT scanner, which the company calls the 1st that's "right for physicians in every clinical specialty."

GE Healthcare lands FDA nod for low-dose CT

GE Healthcare's (NYSE:GE) this week touted a new FDA win for its latest in CT scanner technology, saying the Revolution* CT^ is the 1st of its kind that's right for "every clinical specialty."

Analogic wins FDA clearance for handheld Sonic Window vascular ultrasound

April 9, 2014 by Brad Perriello

Analogic says it won 510(k) clearance from the FDA for its Sonic Window, a handheld ultrasound device for visualizing the vasculature for peripheral IV access.

Analogic wins FDA clearance for handheld Sonic Window vascular ultrasound

Analogic (NSDQ:ALOG) said it won 510(k) clearance from the FDA for its handheld Sonic Window ultrasound device, designed to help caregivers view the vasculature to guide peripheral IV placement.

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GE Healthcare lands FDA clearance for Q.Clear imaging

April 9, 2014 by Arezu Sarvestani

Technology giant GE Healthcare lands U.S. regulatory clearance for its Q.Clear medical image reconstruction technology.

GE Healthcare lands FDA clerance for Q.Clear imaging software

GE Healthcare's (NYSE:GE) won FDA clearance for its latest image reconstruction technology, the Q.Clear system for use with PET/CT scanning.

Medtronic wins CE Mark for Evera MRI SureScan ICD

April 9, 2014 by Brad Perriello

Medtronic says it won CE Mark approval in the European Union for its Evera MRI SureScan implantable cardiac defibrillator, claiming it as the world's 1st ICD approved for full-body magnetic resonance imaging scans.

Medtronic wins CE Mark for Evera MRI SureScan ICD

Medtronic (NYSE:MDT) said it won CE Mark approval in the European Union for the world's 1st market-cleared implantable cardiac defibrillator that's safe for full-body magnetic resonance imaging scans, its Evera MRI SureScan ICD.

The Evera device is slated for an immediate launch in Europe, according to a press release.

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