Winston-Salem, North Carolina, September 22, 2026
Myrava, LLC, formerly known as Ricoh 3D for Healthcare, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new patient-specific 3D-printed bolus device, marking an important development in personalized radiation therapy. The device is designed to help radiation therapy professionals achieve greater dose delivery control and treatment accuracy by creating a customized bolus that matches an individual patient’s anatomy and radiation treatment plan. Myrava said the clearance supports its broader objective of expanding access to personalized medical devices and point-of-care manufacturing across healthcare systems.
Patient-Specific Design for Radiation Therapy
A bolus is a radiotherapy accessory positioned directly on a patient’s skin to help clinicians control the radiation dose delivered during treatment. Myrava’s new device is manufactured specifically for each patient according to the radiation therapist’s design and the specifications contained in the patient’s treatment plan. By matching the device to individual anatomy, the technology is intended to address limitations associated with traditional bolus materials and off-the-shelf solutions, which may not provide the same level of anatomical conformity or treatment-plan alignment. The Myrava Bolus is produced using a direct 3D-printing workflow rather than conventional molding or manual fabrication. The company states that the device is created from DICOM treatment plan data containing radiotherapy structure information, reducing the need for clinicians to perform additional software-based design or manual bolus construction. This workflow is intended to simplify preparation while supporting reproducible positioning during radiation treatment.
3D Printing Designed to Improve Clinical Workflow
Myrava’s patient-specific bolus uses a flexible, translucent material designed to conform to the patient’s anatomy while allowing clinicians to visually check underlying skin features during positioning. According to the company, the material and customized design are intended to improve patient comfort and placement accuracy compared with less personalized approaches. The device is also designed for repeated use on the same patient throughout a treatment cycle, provided it is cleaned and maintained according to its Instructions for Use. The company also highlights potential workflow advantages for radiation therapy teams. Rather than manually constructing a bolus or creating a mold, the clinical team provides the appropriate treatment-plan files, after which the device can be manufactured through Myrava’s production process. The company says its point-of-care manufacturing model can bring production closer to clinicians and patients, potentially supporting faster turnaround and iterative collaboration between manufacturing and radiation therapy teams.
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Myrava Expands Personalized Medical Device Portfolio
The new clearance builds on Myrava’s broader experience with FDA-cleared patient-specific medical devices and additive manufacturing. The company operates under an ISO 13485:2016-certified quality system and maintains FDA-registered point-of-care manufacturing locations. Its existing regulatory portfolio includes 510(k) clearances covering patient-specific anatomic modeling applications across areas such as craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast procedures. Myrava said the new radiation therapy clearance expands its use of 3D printing and advanced manufacturing at the clinical point of care, providing hospitals and health systems with another option for customized medical-device production. The company is also presenting the Myrava Bolus at the ASTRO Annual Meeting in Boston from September 27–29, 2026, where clinicians and healthcare professionals can learn more about the technology and view demonstrations.
The FDA clearance represents a regulatory milestone for Myrava as it expands its portfolio of patient-specific medical devices. By combining treatment-plan data, 3D printing, flexible materials, and point-of-care manufacturing, the company is positioning its new bolus technology as a personalized tool for radiation therapy teams seeking consistent positioning, streamlined preparation, and anatomy-matched treatment support.
Source: Myrava press release
