3D-Printed Intraoral Device Enhances Head and Neck Radiotherapy Accuracy

Ensuring consistent immobilization and soft-tissue positioning is central to safe, effective head and neck radiotherapy, where protection of organs at risk must be balanced with dose accuracy. However, variability in oral appliances and patient setup can increase toxicity risks and disrupt clinical workflows. Addressing these challenges, a new patient-specific intraoral system provides millimeter-accurate, 3D-printed immobilization and has been recognized as the “Best New Radiology Technology Solution” of 2026.

Kallisio’s (Baltimore, MD, USA) Stentra is a patient‑specific intraoral positioning and immobilization solution for head and neck cancer care. Recognized by the 10th annual MedTech Breakthrough Awards program, Stentra is designed to enhance dose‑delivery precision and improve protection of organs‑at‑risk (OARs) by standardizing oral cavity immobilization and tongue displacement. The designation highlights a digitally enabled approach to addressing reproducibility and setup consistency in radiotherapy.

Image: FDA-cleared Stentra patient-tailored oral immobilization solution delivers a custom fit and case-specific tongue displacement to optimize dose delivery and protect healthy tissues in head and neck cancer radiation therapy (Photo courtesy of Kallisio)

Stentra combines optical scanning, automated design, and rapid additive manufacturing to produce millimeter‑accurate, 3D‑printed devices tailored to each patient’s oral anatomy and radiation treatment plan. Devices are delivered within 72 hours and supported by ISO 13485‑aligned quality systems. The solution is also CPT‑reimbursable (Current Procedural Terminology).

The platform holds both U.S. Food and Drug Administration (FDA) clearance and a CE mark. Reported operational gains include recovered linear accelerator (LINAC) capacity and reductions in repeat simulations and unplanned interventions. The awards program recognizes technologies that are reshaping how care is delivered worldwide.

“Kallisio redefines how precision oncology solutions are designed, governed, and scaled. Radiation should treat cancer without the risk of compromising healthy tissue, but inconsistent immobilization can lead to patient risk. Generic or handcrafted oral appliances are variable in quality, contributing to toxicities, treatment interruptions, and operational inefficiencies,” said Steve Johansson, managing director, MedTech Breakthrough.

“Kallisio’s Stentra transforms variability into precision. Combining leadership, evidence, and economic relevance, Stentra is not just digital health; it is digitally enabled medical technology with proven real-world impact,“ added Johansson.

“Behind every personalized solution is a measurable reduction in patient pain, treatment delays, and clinical workflow complexity, all backed by real-world evidence. Early Stentra data shows up to seven minutes saved per treatment fraction, four hours of LINAC capacity recovered per patient course, and significant decreases in simulation re-scans and unplanned interventions for side effects" stated Rajan Patel, CEO of Kallisio.

"We’re honored to be recognized by MedTech Breakthrough, and proud to serve as a strategic partner to hospitals and clinics seeking anatomy-driven solutions that improve outcomes while easing the burden on care teams,” said Patel.

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