Myrava 3D-Printed Bolus Wins FDA 510(k) for Radiotherapy

The Myrava 3D-printed bolus has cleared the US Food and Drug Administration (FDA). The 510(k) nod covers a patient-specific bolus device used in radiation therapy. Myrava was formerly known as Ricoh 3D for Healthcare.

What the Myrava 3D-printed bolus is

The Myrava 3D-printed bolus goes by two names. The first is Myrava Bolus. The second is 3D Bolus. It is an accessory placed on the patient's skin during treatment.

The bolus is designed for each patient. That design flows from the radiation therapist's plan. It also flows from the specs of that patient's treatment.

The bolus is built via direct 3D printing. It is not cast from a mould. That is the core split from older bolus workflows.

How the Myrava 3D-printed bolus is used

The Myrava 3D-printed bolus aims to help clinicians in two ways. The first is radiation dose delivery control. The second is patient positioning during radiotherapy.

The bolus uses a translucent, flexible material. This supports patient comfort. It also lets clinicians check underlying skin features during set-up.

The bolus can be reused on the same patient across the treatment cycle. That reuse rule holds when the bolus is kept per its Instructions for Use.

Point-of-care manufacturing footprint

The Myrava 3D-printed bolus can be made at co-located point-of-care sites. Myrava runs FDA-registered locations for that.

One site sits at Advocate Health in North Carolina. A recently opened site sits at IU Health.

Turner on the clearance

Myrava CEO and co-founder Gary Turner framed the clearance around clinician tools and patient comfort.

Turner said: "FDA 510(k) clearance of our patient-specific bolus marks a significant step forward in our mission to empower clinicians with customised tools to help advance treatment precision and patient comfort."

Turner added: "By leveraging our expertise in advanced manufacturing and healthcare innovation, we are helping radiation therapy teams deliver reliable and reproducible outcomes."

Turner closed on the point-of-care angle.

Turner added: "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."

Where the Myrava 3D-printed bolus sits in Myrava's portfolio

The bolus clearance adds to a wider FDA 510(k) footprint. Myrava already holds clearances for diagnostic anatomic modelling. Those cover several fields.

The current cleared list covers craniomaxillofacial, orthopaedic, cardiovascular, neurological, gastrointestinal, genitourinary and breast applications.

Why the Myrava 3D-printed bolus matters

Bolus is a small but real step in a radiotherapy plan. It shapes surface dose. It also matters for skin sparing. Poor fit can push dose off target.

Many teams still use gelatin sheets, wet cloths, or other makeshift bolus products. Those may not match a patient's anatomy. They may not match the treatment plan either.

For radiation oncology teams, medical physicists, and hospital procurement, the Myrava 3D-printed bolus offers a patient-specific option on-site. Coverage on Medigear.uk tracks the US rollout, adoption at Advocate Health and IU Health, and side-by-side data with mould-cast bolus workflows.

Source: Originating coverage based on Medical Device Network reporting by Salong Debbarma, September 23, 2026, on FDA 510(k) clearance of Myrava's patient-specific 3D-printed bolus device for radiation therapy. URL: https://www.medicaldevice-network.com/