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After receiving FDA 510(k) clearance to market its fully-automated radiological image processing software, Customize, and its pre-operative planning for shoulder arthroplasty earlier this year, 3D-Side has now received 510(k) clearance for pre-operative planning of ankle replacement surgery.
Customize displays surgical planning options that are created based on 3D CAD files, generated from multi-slice DICOM data and x-ray-based information, using Artificial Intelligence during the segmentation process.
The web-based platform allows physicians to review a 3D pre-operative planning of the reconstruction of the ankle pathology.
Customize includes implant libraries, providing the ability to achieve ideal positioning, sizing and orientation of talus and tibia components based on the physician’s input.
After physician’s approval, the final plan is saved and can be used as a reference during surgery.
Customers are currently being onboarded with this new pre-operative software, with official launch expected in 3Q22.
Source: 3D-Side
