Advanced Bionics launches Clarion 1.2 cochlear implant in U.S. following FDA approval Aug. 2.
This article was originally published in The Gray Sheet
Executive Summary
ADVANCED BIONICS CLARION 1.2 COCHLEAR IMPLANT SHIPMENTS BEGIN following FDA approval Aug. 2 of a premarket approval application supplement for the device. A larger version of the device, the Clarion 1.0, was approved on March 29 ("The Gray Sheet" April 15, p. 10), however, the company delayed a full-scale launch until receiving a green light from the agency to commercialize the 1.2 model. The firm is no longer manufacturing the first generation device.
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