3D Systems Announces FDA 510(k) Clearance Expanding VSP Orthopedics Indications to Include Skeletally Mature Adolescents [Yahoo! Finance]
3D Systems Corporation (DDD)
Last 3d systems corporation earnings: 2/26 04:01 pm
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Source: Yahoo! Finance
ROCK HILL, S.C., Dec. 15, 2025 (GLOBE NEWSWIRE) -- 3D Systems (NYSE: DDD) today announced that the U.S. Food and Drug Administration has granted 510(k) clearance expanding the indications for its VSP ® Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents of normal bone stature, in addition to adults. Key Investment Highlights Immediate commercial acceleration : Eliminates case-by-case compassionate-use approvals and hospital IRB reviews previously required for these adolescent patients, streamlining workflows and converting off-label usage into standard, reimbursable procedures at leading centers. Targets high-acuity, underserved segment Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20 (American Cancer Society, SEER estimates). Additional 2,600 primary bone cancer cases in young adults (20–39) now fully in-scope. Thousands of complex lower-limb osteotomies and re
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