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Personalized cancer medtech Kallisio has launched an expanded access program aimed at connecting head and neck cancer patients with Stentra, its FDA-cleared, custom-fit 3D printed intraoral device used during radiation therapy. The program is designed to reach eligible patients directly, even at treatment centers that have not yet adopted the technology.
Stentra received FDA 510(k) clearance (K232293) and is built from a digital scan of each patient’s mouth. Worn throughout every radiation session, the device holds the tongue, lips and other oral structures in a fixed position, helping ensure the radiation beam reaches its intended target consistently across the full course of treatment while sparing surrounding healthy tissue.
Stentra, an FDA-cleared Custom Mouthpiece for Head and Neck