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● FDA-Cleared • CE-Marked • 1M+ Cases Analyzed
See cancer before it hides. Decide with AI certainty.
Koios Laboratories is the ultrasound intelligence layer for breast, thyroid and OB-GYN. Our Koios DS engine turns every B-mode sweep into a BI-RADS-aligned second opinion — in 2.3 seconds, inside your PACS.
94.7%
Sensitivity in multi-center breast study (n=12,400)
Sensitivity in multi-center breast study (n=12,400)
-38%
Reduction in benign biopsies recommended
Reduction in benign biopsies recommended
2.3s
Median inference per lesion, on-prem or cloud
Median inference per lesion, on-prem or cloud
Lesion #A-4421Probably BenignBI-RADS 3 • 12% malignancy
Shape / Margin / EchoOval • CircumscribedAuto-measured 11.4 × 7.2 mm
Prior comparisonStable 14 moNo suspicious change
Recommendation6-mo follow-upAligned to ACR guidelines
KOIOS DS BREAST • THYROID TIRADS • OB-GYN • PACS INTEGRATION • BI-RADS ALIGNMENT • FDA CLEARED • KOIOS DS BREAST • THYROID TIRADS • OB-GYN • PACS INTEGRATION • BI-RADS ALIGNMENT • FDA CLEARED •
01 — About Koios
Laboratory born in the reading room, trained on real chaos.
Founded by radiologists, physicists and ex-NVIDIA engineers, Koios Laboratories exists for one moment: when a sonographer freezes the frame and asks — is this cancer?
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Chicago • New York • Amsterdam
68 scientists • 14 radiologists-in-the-loop • ISO 13485 certified lab
68 scientists • 14 radiologists-in-the-loop • ISO 13485 certified lab
We don't replace radiologists. We remove doubt.
Ultrasound is operator-dependent, noisy and rushed. Koios DS watches 400+ morphologic features — shape, orientation, margin indistinctness, posterior shadowing, vascularity — and fuses them into a calibrated malignancy score that speaks fluent BI-RADS.
✓Trained on 1.2M annotated sweeps from 38 sites, 6 vendors (GE, Philips, Siemens, Canon, Samsung, Mindray), all breast densities.
✓Prospective validation: 12,400 lesions, AUC 0.929, specificity 85.3% at 95% sensitivity — published & peer-reviewed.
✓Zero-click workflow: auto-lesion detection, auto-calipers, auto-report sentence to PowerScribe & Nuance.
✓Explainable: every score shows saliency heatmap + feature contribution, auditable for tumor boards.
2014 — Founded as Koios Medical spin-out
First neural net for breast ultrasound at Univ. of Chicago.
First neural net for breast ultrasound at Univ. of Chicago.
2019 — FDA clearance Koios DS Breast v2
Deployed in 400+ US breast centers.
Deployed in 400+ US breast centers.
2024 — Koios Laboratories unified platform
Breast + Thyroid + Smart Quality + Fetal biometry in one API.
Breast + Thyroid + Smart Quality + Fetal biometry in one API.
2026 — Autonomous QA & triage
Real-time probe guidance: “tilt 12° left, add gel” — live.
Real-time probe guidance: “tilt 12° left, add gel” — live.
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Physics-first AI
We model speckle, attenuation and elastography physics before deep learning. Less hallucination, more causality.
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Regulated & secure
FDA 510(k), CE MDR, HIPAA + GDPR, SOC 2 Type II. On-prem inference — images never leave your firewall if you don't want.
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Vendor-neutral
DICOM-native. Works with any PACS/VNA, any ultrasound cart from 2016+. Go-live in 11 days median.
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Equity by design
Balanced training across age, BMI, density and ethnicity. Performance gap <1.8% across subgroups.
1.2M+
Lesions analyzed annually
650+
Hospitals & imaging centers live
0.929
AUC breast malignancy classifier
31%
Fewer recalls in screening US
02 — Technology
Four engines. One calm reading room.
From raw RF to report sentence — the full stack that makes ultrasound deterministic.
👁️
Koios DS Breast™
Detection + classification + BI-RADS 2/3/4A/4B/4C/5 mapping. Auto-orientation (parallel vs not), margin analysis, posterior features. Outputs calibrated risk 0-100% with operating points you control.
Use: diagnostic workup, second-look, dense-breast screening, biopsy decision.
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Koios Thyroid TIRADS
ACR-TIRADS auto-scoring from transverse + longitudinal clips. Nodule segmentation, composition, echogenicity, foci. FNA recommendation with shared-decision PDF for patients.
Result: -27% unnecessary FNAs in 2025 multicenter trial.
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SmartScan Quality
Live probe guidance + image quality score. Detects foreshortening, shadowing, inadequate gain/depth. Voice prompt: “Sweep slower — lesion at edge.” Cuts technologist rescan rate by 41%.
✓Works on cart via edge box (Jetson Orin, 28W)
✓Telemedicine mode for rural & mobile units
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Koios API + Report Writer
One REST/DICOM API returns JSON: boxes, masks, scores, BI-RADS, key images. Auto-generates structured report + patient letter in 14 languages. Epic, Cerner, Sectra, Intelerad ready.
POST /v3/analyze → { "risk":0.12, "birads":"3", "action":"follow-up" }
03 — Workflow
From freeze to signed report in 47 seconds.
01
Acquire
Sonographer freezes lesion in 2 orthogonal planes. Koios listens via DICOM node — no clicks.
02
Analyze
Auto-contour + 400 features + prior comparison. Heatmap shows why — spiculation here, shadowing there.
03
Decide
Risk dial + BI-RADS + similar cases from atlas of 90k. One-click accept, adjust, or send to tumor board.
04
Document
Structured findings, measurements, key images pushed to PACS & EHR. Patient letter auto-translated.
Integration
IT loves us. Really.
No rip-and-replace. DICOM C-STORE + HL7/FHIR, SAML SSO, audit logs, on-prem or VPC. infosec packet ready, pen-tested yearly. Median go-live 11 days, training 45 minutes.
04 — Clinical evidence
Not a demo. Data.
Peer-reviewed, prospective, multi-vendor. The reason 650+ sites trust the teal dot.
ACRIN-style trial 2024
AUC 0.929, sens 94.7%, spec 78.2%. 12,400 lesions, 38 sites. Readers + AI beat readers alone by +11.4% specificity (p<0.001).
Biopsy reduction
-38% benign biopsies when downgrading BI-RADS 4A → 3 with AI low-risk + stable priors. Zero cancers missed at 2-year follow-up.
Equity audit 2025
Performance delta 1.8% across density C/D vs A/B, 1.2% across race groups. Published with STARD-AI checklist.
What radiologists say after 30 days
4.8/5
“I trust the negative” — confidence score
“I trust the negative” — confidence score
-22%
Reading time per complex case
Reading time per complex case
92%
Would not go back to reading without Koios
Would not go back to reading without Koios
05 — Lab journal
News, releases & peer review.
Fresh from Chicago bench to bedside. Click any story for the full briefing.
06 — Team
Physicists who read scans. Doctors who code.
Dr. Maya Chen, MD
Chief Medical Officer • ex-UChicago Breast Imaging. 18y, 60k+ ultrasounds read.
Jonathan Koi, PhD
CEO & Co-founder • Ultrasound physics, 42 patents. Believes AI should whisper, not shout.
Priya Nair, ML Lead
Head of AI • ex-NVIDIA Clara. Built calibration layer that made FDA reviewers smile.
Sofia Alvarez, RDMS
Head of Clinical Success • Trained 4,000+ sonographers. Queen of “one more sweep”.
07 — FAQ
Asked in every demo.
Short answers. Long infosec packet available on request via contact form below.
Is Koios DS FDA-cleared?
Yes. Koios DS for Breast is FDA 510(k)-cleared and CE-marked under MDR as decision support (not autonomous diagnosis). Thyroid module is FDA-pending, available for research/clinical evaluation.
Will it work with our machines and PACS?
If it speaks DICOM, yes. Validated on GE LOGIQ, Philips EPIQ/Affiniti, Siemens Acuson, Canon Aplio, Samsung RS, Mindray Resona. PACS: Sectra, Intelerad, Change, Fuji, Agfa, plus cloud VNA.
Do images leave our hospital?
Your choice. Edge on-prem box keeps everything inside firewall with full audit trail. Cloud VPC option for multi-site comparison and auto-updates. Both HIPAA/GDPR compliant.
How long is implementation?
Median 11 days: Day 1-2 DICOM routing, Day 3-5 calibration to your BI-RADS thresholds, Day 6-10 shadow reading, Week 3 go-live + 45-min training.
What about reimbursement?
Customers typically use existing ultrasound + CADx workflows; our team provides coding guides, payer letters and ROI model (biopsy avoidance + throughput). Average payback 4.7 months.
Limited 2026 pilot slots • 3 left in Q4
Put the teal dot
Put the teal dot
on every ultrasound.
Get a 20-minute live demo on your own de-identified cases. We’ll show risk scores, heatmaps and report sentences — no sales theater.
Or write to care team via form — on-prem, VPC, academic pricing available.