AXNX - FDA approves Axonics' third-generation implantable neurostimulator

Axonics Modulation Technologies (AXNX) receives PMA supplement approval from the FDA for its third-generation implantable neurostimulator ((INS)). The third-generation INS upgrades the embedded software in the INS and the functionality of the patient remote control. Shipment of the third-generation INS and patient remote control is expected to begin on March 1, 2021.The FDA previously approved Axonics' second-generation rechargeable INS in April 2020, which extended the recharge interval to one hour each month.

For further details see:

FDA approves Axonics' third-generation implantable neurostimulator