Mureva Phototherapy and Siemens Healthineers Expand Access to FDA-authorized Oral Mucositis Treatment

BRECKSVILLE, Ohio, Sept. 26, 2026 /CourierPR/ -- Mureva Phototherapy and Siemens Healthineers have entered into a co-marketing agreement to expand access to Mureva, the first FDA-authorized intraoral device for radiation-induced oral mucositis (OM). This collaboration aims to bring a practical solution to radiation oncology practices, enabling them to deliver guideline-recommended photobiomodulation (PBM) within their existing workflows.

Mureva Phototherapy Inc. received FDA De Novo authorization in 2025, establishing a new Class II classification for intraoral phototherapy devices. The company's flagship device, which received FDA Breakthrough Device Designation, was supported by a recently published, randomized, double-blind, sham-controlled pivotal trial. The trial, which was presented at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting and published in Supportive Care in Cancer in 2026, demonstrated that Mureva significantly reduced the incidence of severe OM during radiation therapy compared to a sham treatment. No device-related adverse events were reported in the study.

Oral mucositis is a common side effect of radiation therapy for head and neck cancer, often causing debilitating pain and affecting a patient's ability to eat and swallow. According to global guidelines from the MASCC/ISOO, intraoral photobiomodulation is recommended for the prevention of OM in adults undergoing radiation therapy for head and neck cancer. However, traditional approaches to delivering PBM can be resource- and time-intensive, making it difficult to integrate into routine care.

Mureva's device is designed to be user-friendly and efficient. It delivers a 10-minute treatment using two soft, flexible intraoral mouthpieces that can be used daily. The treatment can be easily incorporated into existing ARIA® workflows, supporting efficient treatment scheduling, streamlined charge capture, and documentation without requiring a custom software interface.

Siemens Healthineers is committed to helping radiation oncology providers improve both clinical outcomes and the patient experience.

Under the agreement, the companies will coordinate customer education, sales enablement, digital promotion, and engagement at select industry events. Radiation oncology teams interested in learning more about Mureva can contact their local Siemens Healthineers representative or visit the Mureva website at murevapt.com.