Exo vs Iterative Health
Exo and SKOUT serve different rooms. Exo's pages sell a pocket-sized ultrasound scanner with cardiac, lung and fluid AI to the clinician at the bedside, and its case studies come from Fort Bend County EMS and Geisinger. openFDA carries eight Exo decisions, the newest AI Platform 2.2 (K260217) on February 24, 2026. An August 2026 release offers the scanner without a subscription after a one-time activation, with the price handled through Exo's store or sales team.
SKOUT, from Iterative Health, is for an endoscopy unit. It marks colorectal polyps on the live colonoscopy video, and FDA lists six clearances for it, K213686 on August 12, 2022 through K253664 on December 22, 2025. The company's home page now leads with clinical research for providers and sponsors.
In the 2022 Gastroenterology randomized trial, run by the sponsor, adenomas per colonoscopy rose from 0.83 to 1.05 (P=.002), while adenoma detection rate moved from 43.9% to 47.8% at P=.065, short of significance.
Radiology · Reviewed November 2, 2026
Exo
by Exo Imaging, Inc.
Handheld ultrasound with FDA-cleared AI for cardiac, lung and fluid assessment, for point-of-care clinicians.
Iterative Health
by Iterative Health · founded 2017
Real-time AI polyp detection for colonoscopy with the FDA-cleared SKOUT system, for endoscopists and endoscopy centers.
When to pick each one
Exo
- Pocket-sized ultrasound with cardiac, lung and fluid AI
- Eight FDA decisions, newest AI Platform 2.2 in February 2026
- Subscription-free option after one-time activation, August 2026 release
Iterative Health
- Colonoscopy polyp detection on the live video feed
- Trial rose from 0.83 to 1.05 adenomas per colonoscopy
- Six FDA clearances from K213686 to K253664
Score
Each row shows points earned of points available under the published rubric.
Exo
28of 100
Iterative Health
42of 100
| Dimension | Exo | Iterative Health | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 0 / 18.2 | 0 / 18.2 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Exo
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Iterative Health
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo request only. |
Evidence
Exo
FDA decisions
K260217 (opens in new tab)510(k)2026-02-24
AI Platform 2.2 (AIP002)
K243239 (opens in new tab)510(k)2025-04-24
Lung AI (LAI001)
K242359 (opens in new tab)510(k)2024-11-20
Strain AI (SAI001)
K240953 (opens in new tab)510(k)2024-08-05
AI Platform 2.0 (AIP002)
K232501 (opens in new tab)510(k)2023-11-17
AI Platform (AIP001)
Show 3 more
K230497 (opens in new tab)510(k)2023-06-22
Bladder AI (AIBV01)
K222198 (opens in new tab)510(k)2022-11-09
Exo Iris (EI2001)
K211527 (opens in new tab)510(k)2021-08-20
Exo Iris
Iterative Health
FDA decisions
K253664 (opens in new tab)510(k)2025-12-22
SKOUT system
K251126 (opens in new tab)510(k)2025-05-09
SKOUT system
K241508 (opens in new tab)510(k)2024-07-03
SKOUT system
K240781 (opens in new tab)510(k)2024-04-19
SKOUT system
K230658 (opens in new tab)510(k)2023-04-07
SKOUT system
Show 1 more
K213686 (opens in new tab)510(k)2022-08-12
SKOUT Software
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Exo | Iterative Health |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2017 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
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Acute-care triage, mammography screening, CCTA plaque analysis, mobile MRI. 30+ FDA-cleared platforms across stroke, oncology, cardiac. Enterprise sales only — we compared what's deployed where.