About Trial
A two-phase prospective clinical trial evaluating the use of OMEA™, an AI-based software system for the automated obstetric ultrasound imaging for first-trimester NT exams (13 diagnostic views, head-to-toe). The task involved capturing 13 diagnostic views, assessing 77 quality criteria, and obtaining 2 measurements (NT and CRL). Conducted across two clinical sites in the US, the trial analyzed 228 examinations and 3,420 acquisitions performed by 8 experienced maternal-fetal medicine sonographers (4-22 years of routine OB imaging experience, currently practicing at OB or MFM offices). Phase 1 compared manual versus OMEA™assisted workflows to determine time savings and potential capacity gains on using AI; Phase 2 evaluated the benefits of using OMEA™ to boost capacity, revenue, and also assessed the feedback of the sonographers involved in the study.
Key Findings
● Performance and Workflow Impact: Sonographers assisted by OMEA™ achieved 33.6% shorter median scan times (8.17 vs. 12.30 minutes) while simultaneously improving their exam completeness from 78.6% to 92.05%. Crucially, they also achieved >90% completeness across all BMI ranges (17-60) and scan durations (determined by fetal position, movement, body habitus), ensuring imaging consistency and speed regardless of workflow challenges. Notably, there was also a median reduction of 75% in keystrokes for each exam (150 to 38).
● Operational and Capacity Impact: Standardized scan times of the OMEA™ assisted workflow eliminate scheduling unpredictability, enabling tighter appointment slots, fewer cascading delays, and optimized room/machine utilization. This consistency allows practices to schedule complex cases (e.g., high-BMI patients) with the same time-certainty as routine cases, while adding 1-3 additional exam slots (20-30 mins) per sonographer daily within existing shift hours.
● Economic Impact: With additional daily capacity of a median of 2 scans per day per sonographer with OMEA™assisted workflows, practices can unlock around 500 additional exams per year per sonographer, resulting in additional revenue opportunity of $125k per full-time equivalent (FTE) sonographer, without additional spend on staffing, equipment, or facility costs.

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