Global Approvals Snapshot September 2019
Executive Summary
September’s approvals include the US FDA’s approval of Axonics sacral neuromodulator for fecal incontinence and AMO’s Star S4 IR excimer laser for photorefractive keratectomy.
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FDA Approves Axonics’ Neuromodulation Device For Incontinence
The US FDA has approved r-SNM sacral neuromodulation system for treating chronic fecal incontinence and Axonics expects the agency to approve it for overactive bladder and urinary retention in the next few weeks. The company expects r-SNM to compete with Medtronic's Interstim non-rechargeable sacral neuromodulation system.
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