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FDA news: Covidien, Preventice, Precision Spine win FDA clearances

Tue, 09/11/2012 - 1:17pm
Mass Device

The FDA clears Covidien's LigaSure surgical tool, a wireless cardiac monitor from Preventice and Mayo Clinic and a new spinal plating system from Precision Spine.

510k

A trio of medical device companies won nods from the FDA's Center for Devices & Radiological Health this week, including a surgical sealer, a wireless cardiac monitor and a spinal plating system

Covidien (NYSE:COV) said it won 510(k) clearance from the FDA for its LigaSure surgical sealer/divider for ear, nose and throat procedures.

The clearance means the device, which is designed to be small enough to successfully maneuver during ENT procedures, can be used in thyroidectomies, parotidectomies and open ENT procedures. More than 160,000 such operations are performed annually in the U.S., according to a press release.

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