BioticsAI Clinical Intelligence Platform
AI-powered fetal ultrasound screening validation and automated reporting
Company profile
Company profile
BioticsAI is a medical imaging AI company specializing in prenatal ultrasound quality assurance and fetal anomaly detection. The company's Clinical Intelligence Platform validates the completeness and quality of fetal anomaly screenings, localizes fetal vulnerabilities, and automates report generation for obstetricians and maternal-fetal medicine specialists. Founded at the intersection of clinical medicine and computer vision engineering, BioticsAI was created to standardize ultrasound screenings and ensure every mother receives comprehensive prenatal care. The platform provides real-time plane capture, imaging quality assessment, and anatomical structure evaluation across nearly 70 anatomical regions, designed to facilitate compliance with AIUM and ISUOG quality guidelines. BioticsAI has received FDA 510(k) clearance for routine midtrimester anatomy examinations (T2 and T3), making it the first US-founded company to gain FDA clearance for standard midtrimester fetal ultrasound examinations. The platform integrates seamlessly with EHR, PACS, and HIS systems, providing interoperable and real-time data syncing. The company serves health systems, clinics, and maternal-fetal medicine practices, with clinical validation led by experts from Stanford University, UC Davis, UCLA, Indiana University, and Maimonides Medical Center.
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Recorded integration context: DICOM-compliant ultrasound machines, EHR systems, HIS systems, PACS.
Company milestones
FDA 510(k) clearance received in January 2026 for routine midtrimester fetal anatomy examinations. Won TechCrunch Disrupt Startup Battlefield in September 2023, taking home $100,000 prize among 3000+ startups.
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02 · Flagship portfolio
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AI-powered fetal ultrasound screening validation and automated reporting
03 · Research intelligence
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Research
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Clinical validation
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Regulatory
K250959 · 510k · Dec 22, 2025
04 · Company-reported outcomes
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Most comprehensive AI product for fetal anatomy screenings
Automated report generation saves hours while maintaining compliance
Identifies errors, localizes problematic anatomical views, identifies fetal anomalies
Comprehensive AI tool for meeting AIUM & ISUOG quality guidelines in fetal ultrasound screenings
Most comprehensive AI product available with coverage across nearly 70 anatomical regions
05 · Leadership
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06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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