#United States #FDA Approval #3D Printing #Winston-Salem #Myrava

Myrava Gains FDA Approval for Cutting-Edge 3D Printed Bolus Device

Myrava, LLC, renowned for its innovations in healthcare technology, has achieved a significant milestone by securing FDA 510(k) clearance for its latest patient-specific 3D printed bolus device. This state-of-the-art accessory, specifically designed for radiation therapy, stands to revolutionize patient treatment methodologies across healthcare systems in the U.S.

Enhancing Precision in Radiation Therapy

The newly cleared 3D printed bolus is crucial for improving the accuracy and control of radiation dosing during treatment sessions. Traditionally, clinicians have faced limitations with standard bolus materials, which often do not align with the unique anatomical requirements of individual patients. Myrava's device addresses these challenges by providing a solution tailored to the needs of each patient, thus ensuring enhanced treatment precision.

According to Gary Turner, CEO and Co-Founder of Myrava, this advancement not only supports clinicians but also aims to improve patient comfort significantly. The bolus is custom-designed based on each patient's anatomy and the specifications derived from their radiation treatment plan, marking a departure from the one-size-fits-all approach that has long been prevalent in the field.

Key Features of the Myrava Bolus

The Myrava Bolus boasts several noteworthy features that distinguish it from traditional therapy aids:

• - Anatomy-Matched Design: Each bolus is 3D printed based on the specific anatomical data of the patient, ensuring optimal compatibility and effectiveness.
• - Direct Printing Workflow: By utilizing direct 3D printing, the device avoids the need for casting molds, streamlining the manufacturing process.
• - Patient Comfort: Constructed from flexible, translucent material, the bolus allows clinicians to visually confirm the positioning while maximizing comfort for patients during treatment.
• - Reusability: The bolus can be safely reused for the same patient throughout their treatment cycles, provided it is maintained according to guidelines, thus promoting sustainability in medical practices.

Advantages for Radiation Professionals

One of the standout features of the Myrava Bolus is its potential to save time for radiation therapists. By simply supplying the necessary treatment plans in DICOM format, clinicians can bypass additional software requirements and reduce implementation time.
This innovative approach emphasizes Myrava's commitment to enhancing operational efficiency and effectiveness within healthcare settings.

Regulatory Expertise and Future Prospects

Myrava's expansion into 3D printed bolus devices is backed by the company's strong regulatory framework, with FDA clearances already established for a wide range of applications in medical devices. As a leader in leveraging additive manufacturing for clinical applications, Myrava reinforces its stature by ensuring top-tier compliance while advancing patient care technology.

With operational bases at prominent healthcare facilities, including Advocate Health in North Carolina and IU Health, the company is well-positioned to support healthcare providers in deploying these innovative solutions.

Experience Myrava’s Innovations at ASTRO 2026

Healthcare professionals are encouraged to meet the Myrava team at the upcoming ASTRO (American Society for Radiation Oncology) Annual Meeting in Boston, taking place from September 27–29. Attendees can gain insights into the transformative potential of the Myrava Bolus through firsthand demonstrations and discussions with industry experts.

About Myrava, LLC

Myrava, formerly Ricoh 3D for Healthcare, is dedicated to delivering FDA-cleared, patient-specific medical devices through both centralized and point-of-care production. With a mission to support hospitals and healthcare systems, Myrava continues to make strides in personalized medicine by providing robust solutions for surgical planning and diagnostics. For further information, visit myrava.com.