MEDO ARIA is a cloud-based medical imaging software that uses machine learning to help clinicians view, quantify, and generate reports from ultrasound images of infant hips. It supports diagnosis of developmental hip dysplasia (DDH) in newborns and infants up to 12 months, assisting radiologists by automating some image analysis tasks and improving workflow efficiency.
Intended Use
MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.
Technology
MEDO ARIA is a cloud-based standalone software medical device that uses image-based assessment of ultrasound data with manual and semi-automatic landmark placement, alpha angle and coverage measurements, and hip Graf classification to evaluate hip development. It processes imported DICOM ultrasound images and provides visualization, navigation, and report generation tools.
Performance
Safety and performance of MEDO ARIA were evaluated and verified through software verification and validation testing according to IEC 62304 and FDA guidance documents. No new safety or effectiveness questions were raised and software validation activities and life-cycle processes were compliant with applicable standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/13/2020
3 months - 2
FDA Approval
6/11/2020
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