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
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.
You may also be interested in...
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.