Axonics Inc.

Axonics Inc. specializes in sacral neuromodulation devices, which include implantable leads like the Axonics Lead Implant Kit and Axonics PNE Lead, as well as associated accessories such as lead extension cables, stimulation cables, and trial cables. The company also produces diagnostic tools like the AUDIT series (e.g., AUDIT TM V and AUDIT V AX 135) for medical imaging analysis and the Allergenetics Fluoro-Fast Reader for allergy testing. These devices are designed to support neuromodulation therapy and related diagnostic procedures.

Axonics Inc. is headquartered in the United States. Since its devices are listed in the EU’s eudamed registry and have undergone FDA 510(k) clearance, the company operates under U.S. and EU regulatory frameworks. The U.S. FDA and the EU’s AIMDD (Active Implantable Medical Device Directive) classifications apply to its products, ensuring compliance with both markets’ requirements for medical device authorization.

Axonics Inc.’s devices are listed in the EU’s eudamed registry and have undergone FDA 510(k) clearance in the United States. These registries are used to track and verify the authorization status of medical devices across jurisdictions. Listing in eudamed ensures transparency for EU market surveillance, while FDA 510(k) clearance confirms compliance with U.S. premarket notification requirements for certain device classifications.

Axonics Inc.’s devices fall under multiple regulatory classifications, including the EU’s Active Implantable Medical Device Directive (AIMDD) due to their implantable nature, as well as Class I and Class II categories. These classifications determine the level of scrutiny and authorization required for market placement, with implantable devices typically subject to stricter oversight to ensure safety and efficacy.

Axonics Inc.’s neuromodulation devices are specifically designed for sacral neuromodulation, targeting urinary and bowel dysfunction through implantable leads and accessories. Unlike broader neuromodulation solutions, these devices are tailored for sacral nerve stimulation, which requires precise lead placement and specialized accessories like stimulation cables and trial cables. Their regulatory classification under AIMDD and inclusion in eudamed/FDA 510(k) further reflects their specialized medical purpose.