FDA Cleared Myrava 3D Printed Radiotherapy Bolus

The regulatory approval allows the medical firm to produce patient-specific radiotherapy tools for hospitals.

Updated on Oct. 2, 2026 in Healthcare

FDA Cleared Myrava 3D Printed Radiotherapy Bolus

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The FDA granted 510(k) clearance to Myrava for a patient-specific 3D printed bolus used during radiation therapy. This medical device is designed to provide a more precise dose distribution by matching a patient's unique anatomy.

Why it matters

The custom-shaped bolus addresses the limitations of generic, off-the-shelf radiotherapy sheets that often struggle to fit irregular body surfaces correctly. This improves the accuracy of radiotherapy treatments by ensuring the material conforms precisely to a patient's treatment plan.

Myrava maintains ISO 13485:2016 certification for its medical device quality management and operates under SOC 2 compliance. The company prints these bolus layers at FDA-registered sites located within major health systems like Advocate Health and IU Health.

The players

Myrava

Myrava is an independent medical technology company that provides 3D-printed solutions for radiation therapy and diagnostic imaging.

Ricoh USA

Ricoh USA is a major provider of document management solutions and digital services that previously incubated the 3D printing healthcare business.

Advocate Health

Advocate Health is a large nonprofit health system that hosts Myrava printing sites to facilitate on-site medical device production.

IU Health

IU Health is an extensive academic healthcare network that collaborates with Myrava to utilize on-site printing services.

The details

Clinicians provide Myrava with a DICOM package containing the necessary radiotherapy structure files to generate a patient-specific design. The finished bolus is manufactured from a translucent and flexible material that is printed directly without the need for a mold.

2025: Ricoh formed its 3D for Healthcare division.
July 6, 2026: Ricoh USA sold the business to Myrava, Inc.
October 2, 2026: The FDA clearance for the bolus was announced.

Market Landscape

This clearance signals a shift toward decentralized manufacturing where health systems bring production directly into clinical environments. By separating from a large legacy entity like Ricoh, Myrava positions itself to compete more aggressively in the specialized medical 3D printing sector.

Patients undergoing radiation therapy may experience more precise dosing as hospitals adopt these custom-fitted devices. For clinics, this transition eliminates the need to rely on generic sheets that require more manual adjustment for irregular surfaces.

The takeaway

Customized 3D printing technology is increasingly being integrated directly into hospital workflows to improve medical outcomes. Patients should inquire with their oncology teams about the availability of custom-fitted radiotherapy tools during treatment planning.