Myrava Advances Personalized Radiation Therapy With FDA 510(k) Clearance for Patient-Specific 3D Printed Bolus Device

WINSTON-SALEM, N.C., Sept. 22, 2026 /PRNewswire/ -- Myrava, LLC (Myrava), formerly Ricoh 3D for Healthcare, LLC, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new patient-specific 3D printed bolus device. Designed to optimize radiation dosing control and accuracy, this latest clearance marks a key milestone in Myrava's mission to democratize access to personalized medical devices across healthcare systems nationwide.

As a radiotherapy accessory, the 3D Bolus is placed directly on a patient's skin to help clinicians control the radiation dose a patient receives during treatment. Each bolus is manufactured to match the radiation therapists' design for an individual patient and the specifications of their radiation treatment plan. This level of personalization helps address longstanding challenges associated with traditional bolus materials and off-the-shelf solutions which may not align as closely with treatment planning.

"FDA 510(k) clearance of our patient-specific bolus marks a significant step forward in our mission to empower clinicians with customized tools to help advance treatment precision and patient comfort," said Gary Turner, CEO and Co-Founder at Myrava. "By leveraging our expertise in advanced manufacturing and healthcare innovation, we are helping radiation therapy teams deliver reliable and reproducible outcomes. The Myrava Bolus can be manufactured at co-located point-of-care facilities offering additional benefits, such as closer contact to the clinicians for iterative design and faster turnaround times."

Addressing clinical challenges with advanced personalization

Today's radiation oncology teams often rely on gelatin sheets, wet cloths, or other makeshift bolus materials that are not optimized for patient anatomy or treatment plans. Myrava's 3D printed bolus device is intended to help facilitate patient-specific care by offering:

• Anatomy-matched precision: Designed by the radiation therapy professional for each patient's unique anatomical data and radiation plan.
• Direct manufacturing workflow: The device is 3D printed directly, rather than cast from molds.
• Enhanced comfort and visibility: Created using translucent, flexible material that is intended to aid in accurate positioning by allowing visual checks of underlying skin features while optimizing patient comfort.
• Reusable efficiency: Designed to be safely reused on the same patient throughout their treatment cycle when maintained per the Instructions for Use.
• Potential time savings for radiation professionals: Clinicians only need to provide treatment plan, in form of DICOM containing Radiotherapy (RT) structure file. No additional software or manual creation time needed.

Leveraging deep expertise to drive point-of-care advancement

The launch of the Myrava Bolus expands the company's proven track record of bringing additive manufacturing to the clinical frontlines. Myrava has established deep operational and regulatory expertise in managing FDA-registered point-of-care locations—such as at Advocate Health in North Carolina, and its most recent facility at IU Health.

This bolus clearance builds directly onto Myrava's broad regulatory footprint. The company holds FDA 510(k) clearances for diagnostic anatomic modeling across craniomaxillofacial (CMF), orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications. Operating under ISO 13485:2016 certification and maintaining strong SOC 2 security compliance, Myrava provides a secure, reliable foundation for hospitals seeking to scale personalized care.

Experience Myrava Bolus at ASTRO 2026

Connect with the Myrava team at the ASTRO (American Society for Radiation Oncology) Annual Meeting in Boston, September 27–29, at Booth 2926. Attendees will have the opportunity to meet with Myrava leaders and clinical experts to discuss point-of-care manufacturing innovations and receive hands-on demonstrations with Myrava Bolus samples.

About Myrava, LLC

Myrava delivers FDA-cleared, patient-specific medical devices through both centralized and point-of-care manufacturing. The company supports hospitals and health systems with diagnostic anatomic models, surgical planning tools, and scalable production partnerships. To learn more, visit myrava.com.

© 2026 Myrava, LLC. All rights reserved. The content of this document, and the appearance, features and specifications of products and services are subject to change from time to time without notice.

Media Contact:

Beaman Marketing for Myrava, LLC
[email protected] 

SOURCE Myrava, LLC