FDA Cleared Myrava to 3D Print Radiation Boluses
Radiology operators gain access to patient-specific boluses designed to improve dose accuracy and fit on irregular surfaces.
Updated on Oct. 2, 2026 in Healthcare
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The FDA granted 510(k) clearance to Myrava for a 3D-printed, patient-specific bolus used in radiation therapy. The device replaces off-the-shelf tissue-equivalent sheets with a molded, translucent material tailored to individual treatment plans.
Why it matters
Operators can now utilize a device that provides a closer match to clinical dose calculations than standard materials, mitigating fit issues on complex patient anatomy. This clearance enables more precise radiotherapy delivery for clinics adopting patient-specific workflows.
This clearance follows a five-year incubation period by Ricoh USA, which sold the business to Myrava, Inc. on July 6, 2026. The firm maintains ISO 13485:2016 quality certification and operates printing sites within health systems such as Advocate Health and IU Health.
The players
Myrava
An independent medical device manufacturer that operates 3D printing sites directly within major U.S. health systems.
Ricoh USA
A global technology company that incubated this 3D-printing unit for five years before completing a divestiture in 2026.
Advocate Health
A large U.S. health system that hosts active, FDA-registered Myrava printing sites on-premises.
IU Health
A regional healthcare provider that currently hosts Myrava's on-site medical 3D printing infrastructure.
The details
Clinicians initiate the process by sending a DICOM package containing the radiotherapy structure file to Myrava. The company then prints the bolus directly from a flexible material based on the patient's specific treatment plan, bypassing the need for traditional molds. This approach is intended to correct the uneven fit issues that often plague off-the-shelf materials when used on irregular skin surfaces.
Timeline
2025: Ricoh formed the 3D for Healthcare LLC.
July 6, 2026: Ricoh USA announced the sale of the business to Myrava, Inc.
October 2, 2026: FDA clearance announced.
Market Landscape
This development follows the established trend of health systems shifting toward decentralized, point-of-care manufacturing for personalized implants and aids. By clearing a 3D-printed bolus through the FDA 510(k) pathway, regulators are providing a formal framework for devices that deviate from traditional off-the-shelf manufacturing precedents.
Radiology directors should evaluate if their current radiation workflows involve significant time lost to manual bolus fitting, which this technology is designed to eliminate. Finance leads should monitor the transition to these patient-specific devices, as they require integrating DICOM file transfer protocols into the existing treatment planning process.
The takeaway
The transition to directly printed, patient-specific radiotherapy aids reduces material variability and improves dose calculation accuracy. Oncology managers should review the technical compatibility of their current treatment planning software with Myrava's DICOM submission requirements.
Further reading
For more on industry shifts in medical manufacturing, visit Healthcare.
Source note: This article includes information reported by 3D Printing Industry.
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