Maverix Medical Receives FDA Clearance for Narwhal Pro Cryoprobe
Maverix Medical has expanded its cryotherapy portfolio with the U.S. Food and Drug Administration granting 510(k) clearance for its Narwhal Pro Cryo System.
Menlo Park, Calif. – Maverix Medical has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Narwhal™ Pro Cryo System. This marks the company's second console-free cryoprobe designed for lung cancer diagnosis and treatment.
The clearance, granted on September 2, 2026, applies to the Narwhal Pro cryoprobe, which utilizes a single-use nitrous oxide (N₂O) cartridge. A key advantage is its console-free operation, reducing operational costs and maintenance. The Narwhal Pro is optimized for shorter, 600 mm or less, bronchoscopes and is compatible with common Olympus, Fuji, and Pentax scopes via direct adapters.
The Narwhal Pro is indicated for palliative devitalization of tissue during interventional procedures, including the removal of tumors, foreign bodies, and blood clots, as well as for tissue biopsies. Maverix Medical developed this device to address the growing demand for cryobiopsy capabilities with widely used endoscopic instruments.
The diagnostic value of cryobiopsy has been highlighted by the recent FROSTBITE-2 study published in JAMA. The study reported a 10% increase in diagnostic yield compared to traditional forceps biopsies. Maverix Medical CEO Carla Jung stated that the development of Narwhal and Narwhal Pro demonstrates the company's ability to rapidly bring new solutions to market.
Both the Narwhal and Narwhal Pro systems are expected to become broadly available in the United States in 2027 through Thoracent, a Maverix company. They are being positioned as solutions that enable the use of cryobiopsy in more patient cases without significant capital expenditure.