21 Apr 2025
FDA Clearance Confirms MySegmenter’s Role in Diagnostic 3D Printing for Orthopedic and Maxillofacial Surgical Planning Across U.S. Hospitals.
Delaware, USA— 3d surgical is proud to announce that its flagship medical image segmentation software, MySegmenter (v2.0.0), has officially received 510(k) clearance from the U.S. Food and Drug Administration (FDA)for the scope of converting CT/MR images into 3d models for surgery planning and education purposes.
This regulatory milestone solidifies MySegmenter’s position as a trusted tool in the medical imaging ecosystem, supporting clinicians and hospitals across the United States in advancing patient-specific care. This approval now enables hospitals to use 3d printed anatomical models for diagnostic purpose in orthopedic and maxillofacial surgeries.
MySegmenter is a robust, intuitive platform that allows healthcare professionals to segment regions of interest from CT and MRI DICOM images and transform them into high-quality 3D anatomical models. Built with precision, ease of use, and speed in mind, MySegmenter is designed to assist in preoperative planning, custom implant design, and 3D printing workflows for complex surgical cases. With the FDA 510(k) clearance, MySegmenter is now cleared for clinical use in the United States, enabling hospitals, radiology labs, and surgical teams to integrate the software into their clinical pathways for advanced 3D surgical planning and anatomical modeling.
Ravikant Kamal, Co-Founder, at 3d surgical, commented: “Achieving 510(k) clearance is a major step forward in our mission to democratize access to high-quality 3d surgical planning tools.
MySegmenter empowers care teams to visualize anatomy with unmatched clarity and contribute to more confident surgical decisions.”
Key Highlights of MySegmenter:
• Seamless segmentation from DICOM to 3D models
• Semi-automated & advanced manual tools for fine-tuned accuracy
• Finishing operations including wrap, 3D split, and segment-level contour editing
• Export options including STL, JSON, MRK.JSON, and NRRD (R&D version)
• Login-based licensing for flexible access across systems With this FDA clearance, 3d surgical continues to push the boundaries of personalized healthcare, giving surgeons and medical device innovators the tools they need to plan, prototype, and personalize like never before.
To experience the power of MySegmenter, sign up for a free 30-day trial at mysegmenter.com.
For media inquiries or partnerships, contact us at contact@mysegmenter.com.