Us Fda Grants Breakthrough Device Designation For Curvebeam Ai S Ossview Bone Fragility Software

Curvebeam Ai Ltd Announced Its Medical Diagnostic Software, Ossview, Has Received Us Food And Drug Administration (Fda) Breakthrough Device Designation. Ossview Calculates A Structural Fragility Score (Sfs), Which Determines Bone Microstructural Deterioration, A Highly Accurate Indicator For Bone Fragility And Fracture Risk.Ossview Is Investigational Only And Is Not Available For Sale In The United States.The Goal Of The Fda Breakthrough Devices Programme Is To Provide Patients And Health Care Providers With Timely Access To Medical Devices That Provide For More Effective Treatment Or Diagnosis Of Irreversibly Debilitating Diseases By Speeding Up Their Development, Assessment, And Review, While Preserving The Statutory Standards For Premarket Approval.Benefits Associated With Acceptance Into The Breakthrough Devices Programme Include Prioritized Review Of Fda 510(K) Applications.The Current Standard Of Care To Determine Fragility Fracture Risk In Patients Is Bone Mineral Density (Bmd) Measurements Obtained Via Dual Energy X-Ray (Dxa). In Some Cases, The Fracture Risk Assessment Tool (Frax) Software Is Used To Further Identify Fracture Risk. These Approaches Miss Patients Who Are Non-Osteoporotic But Still At Risk For Fragility Fracture

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