Maverix Medical, a healthcare company focused on improving the diagnosis and treatment of lung cancer, announced on Thursday that the US Food and Drug Administration (FDA) granted 510(k) clearance on June 30, 2026 for the Maverix Narwhal Cryo System, a single-use flexible cryoprobe that requires no console.

The system comprises the Maverix Narwhal Cryoprobe and a single-use cryo cartridge, available separately or as a kit. The Maverix Narwhal Cryobiopsy Probe is indicated for palliative devitalisation (destruction) of tissue during interventional procedures by the application of extreme cold and cryo-adhesion, for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumours (palliative recanalisation) and tissue biopsies.

Conventional flexible cryoprobes run off a dedicated cryosurgical console with an external compressed-gas cylinder and footswitch. The Maverix Narwhal Cryoprobe is instead powered by a single-use nitrous oxide (N2O) cartridge activated by an integrated handle, eliminating the requirement to purchase or service a console.

The company says that in bench and animal testing conducted in support of the 510(k) submission, the Narwhal Cryoprobe met all predefined performance and safety endpoints.