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

BRECKSVILLE, Ohio -- 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 …

BRECKSVILLE, Ohio -- 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 …