AXNX - Axonics seeks FDA nod for new rechargeable neurostimulator

Axonics (NASDAQ:AXNX) said it filed a premarket approval supplement with the FDA for its fourth generation rechargeable sacral neuromodulation implantable neurostimulator (INS). The fourth gen rechargeable INS reduces the time needed by a patient to recharge their implanted device to once every six months for one hour, compared to once a month for one hour with the third generation rechargeable INS, the company said in a May 31 press release. Axonics (AXNX) noted that its sacral neuromodulation systems provide patients with overactive bladder and/or fecal incontinence with long-lived, safe, and effective therapy. The company expects the new INS to receive FDA labeling for 20 years of useful life in the body. Axonics (AXNX) expects to get FDA approval for the new product in Q4 2022 and intends to begin shipping the device in Q1 2023.

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Axonics seeks FDA nod for new rechargeable neurostimulator