Medical News Observer

Overview

 Axial3D Insight is a cloud-based service and image segmentation framework for transferring and processing DICOM imaging information. It facilitates the transfer of medical scanner data to an output file. This output file can create physical replicas for various medical applications via additive manufacturing.

Indications

Axial3D Insight intends to convert DICOM imaging data from medical scanners into output files to create physical replicas. These replicas or output files can assist in treatment planning and diagnostic purposes in orthopedic trauma, orthopedic maxillofacial, and cardiovascular fields.

Limitations

It should be used as a complement to other diagnostic methods, indicating that it is not a standalone diagnostic tool. The effectiveness and applicability of the output depend on the quality of DICOM images and the specifics of the case at hand.

Study Results

The validation studies demonstrated the software’s ability to accurately segment images for creating 3D models, with radiologists and physicians confirming the utility and accuracy of the models in clinical settings. The Clinical Segmentation Performance study and the Intended Use validation study underscored the device’s capability to effectively meet its intended purposes ie creating the 3D patient specific model.

Company and FDA Clearance

Axial3D, the company behind Axial3D Insight, specializes in transforming medical imaging into 3D-printed models for surgical planning and patient care. The U.S. Food and Drug Administration (FDA) has granted Axial3D Insight Class II clearance, indicating its safety and efficacy for medical use. This authorization signifies a significant step forward in leveraging 3D printing technology for healthcare, enabling precise and personalized treatment planning for patients across various medical specialties.

Conclusion

The Axial3D Insight is a valuable tool in the treatment preparation and planning stages for various medical conditions. It provides a novel way to visualize and plan surgeries with high precision.

Reference

Axial3D Insight, K222745. 510(k) Premarket Notification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222745.