Crescom has started a clinical proof-of-concept study of 3 pediatric musculoskeletal AI tools with the Mass General Brigham Department of Radiology.
The validation will be conducted by radiologists at Massachusetts General Hospital. Crescom said the study will compare AI-generated readings with expert clinical interpretations and assess clinical validity, usability, and user feedback in a U.S. radiology environment.
The study covers MediAI-BA for bone-age analysis, MediAI-SG for full lower-limb length measurement, and MediAI-SC for scoliosis severity measurement.
MediAI-BA is the only one of the 3 tools described as FDA-cleared in the company announcement. FDA records list MediAI-BA under product code QIH as class II automated radiological image-processing software.
The FDA-cleared indication covers bone-age quantification from 2D posterior-anterior left-hand radiographs in patients 2 to 18 years old. FDA records state that results should not be relied upon alone by pediatric radiologists to make diagnostic decisions.
Performance testing for MediAI-BA used 600 U.S. cases across 5 sites. FDA summary documents state that 89% of cases showed a difference of less than 0.5 years between ground-truth values and software output.
The validation program is scheduled to run through November, according to Korea Biomedical Review, which cited a Korea Biotechnology Industry Organization release.
Crescom said the work is intended to support its North American clinical track record in radiology and pediatric growth-clinic markets. The company also said MediAI-BA has regulatory approval in Korea, Thailand, and Malaysia.
Company:Crescom
Sources
- 510(k) Premarket Notification K250914. Regulatory filing
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