Myrava, formerly known as Ricoh 3D for Healthcare, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its patient-specific, 3D-printed bolus device used in radiation therapy.
Known as the Myrava Bolus or 3D Bolus, the accessory is placed directly on a patient’s skin during treatment. It is designed according to the radiation therapist’s plan for the individual patient and the specifications of their treatment.
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The device aims to help clinicians control radiation dose delivery and improve positioning during radiotherapy.
It is 3D-printed directly rather than cast from a mould.
The bolus uses translucent, flexible material designed to support patient comfort and allow clinicians to check underlying skin features during positioning.
It can be reused on the same patient throughout the treatment cycle when maintained according to its Instructions for Use.
The device can be produced at co-located point-of-care facilities. Myrava operates FDA-registered locations, including one at Advocate Health in North Carolina and a recently established facility at IU Health.
The clearance adds to the company’s existing FDA 510(k) clearances for diagnostic anatomic modelling in craniomaxillofacial, orthopaedic, cardiovascular, neurological, gastrointestinal, genitourinary and breast applications.
Myrava CEO and co-founder Gary 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.
“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.”
The device is intended to address limitations associated with materials such as gelatin sheets, wet cloths and other makeshift bolus products, which may not match a patient’s anatomy or treatment plan.
