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Iterative Health

by Iterative Health  ·  founded 2017  ·  US

Last verified

Real-time AI polyp detection for colonoscopy with the FDA-cleared SKOUT system, for endoscopists and endoscopy centers.

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At a glance

Pricing
No public price. Demo request only.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
2017
HQ
US
On this page

Independent score  ·  By our public rubric

42/100Competitive

Editorial rating 3.0 / 5

How it’s computed →
  • Regulatory & Compliance
    18/28

    FDA cleared (6 K-numbers on record)

  • Clinical Integration
    0/6.6

    No EHR integrations listed

  • Evidence Strength
    0/26

    No peer-reviewed coverage

  • Vendor & Market
    14.4/18

    Mid-tier funding and adoption

  • Sentiment & Transparency
    2.5/5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance18/18

    FDA cleared (6 K-numbers on record)

  • HIPAA / SOC2 / BAA0/10

    No public HIPAA/SOC2/BAA attestation

Clinical Integration

  • EHR integrations (count)0/4

    No EHR integrations listed

  • Top-3 EHR coverage (Epic / Oracle / Athena)0/2

    None of the top-3 EHRs covered

Evidence Strength

  • Peer-reviewed papers0/18

    No peer-reviewed coverage

  • RCT / meta-analysis / systematic review0/8

    No RCT, meta-analysis, or systematic review

Vendor & Market

  • Funding & adoption signal8/12

    Mid-tier funding and adoption

  • Years in market6/6

    Founded 2017 (9 years)

Sentiment & Transparency

  • Pricing transparency3/5

    Pricing on request, no public amounts

Scored November 2, 2026 · Public scoring method v1.2.0

Real-time AI polyp detection for colonoscopy with the FDA-cleared SKOUT system, for endoscopists and endoscopy centers.

No public price. Demo request only.

Evidence record

FDA decisions
Show 1 more
Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, Iterative Health record, https://medaiverdict.com/tools/iterative-health, version November 2, 2026

Change history
View every change to this record

Bottom line

Iterative Health, formerly Iterative Scopes, of Cambridge, Massachusetts, now describes itself as a company that brings research directly into the communities where care happens, and SKOUT, its real time polyp detection software for colonoscopy, is still listed as a product with its own page. FDA's records list six SKOUT clearances, from K213686 in August 2022 to K253664 in December 2025. The evidence is one randomized trial run by the sponsor. An endoscopy group weighing a colonoscopy detection aid on adenomas per colonoscopy has a result to assess. A unit that wants a significant gain in adenoma detection rate sees P=.065 in that trial.

What is SKOUT?

SKOUT is computer aided detection of colorectal polyps on the live video feed during colonoscopy. The vendor says it is trained to spot clinically significant lesions, enriched for sessile polyp detection, with no increase in procedure time. The six clearances sit under one FDA product code, and the summaries for K230658 and K240781 each name the clearance before them as predicate. The last two, from May and December 2025, were filed under the Iterative Health name.

The SKOUT page offers "Schedule a Demo" as its only route and lists no price or processor compatibility.

What did the registration trial show?

The 2022 Gastroenterology randomized trial (PMID 35643173) enrolled 22 endoscopists at 5 centers and compared 677 standard colonoscopies with 682 using the detection aid. Adenomas per colonoscopy were 0.83 against 1.05 (P=.002). Adenoma detection rate was 43.9% against 47.8% (P=.065), which did not reach significance. The trial was sponsor run by Iterative Scopes.

The vendor, citing a 2022 randomized trial, says high performing endoscopists "resected 1 additional adenoma for every 4.5 patients examined with SKOUT, without increasing resection of hyperplastic polyps".

What changed at the company?

The home page now speaks to providers and to sponsors or CROs about GI, hepatology, obesity and cardiology research. A headline on it says Iterative Health closed a $77 million Series C to accelerate clinical research, and Jonathan Ng, MBBS, founded the company in 2017. Whether SKOUT remains actively sold and maintained after the shift is not stated on the company pages.

The verdict

The sponsor run trial behind SKOUT showed more adenomas per colonoscopy and a detection rate gain that was not significant, so an endoscopy unit weighing the first measure has more to go on than one that needs the second. The company's headline business is now clinical research. The vendor says high performing endoscopists resected one extra adenoma for every 4.5 patients examined.

Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.

What it costs

All tiers are custom-quoted. The vendor does not publish per-provider list pricing.

TierMonthlyAnnualNotes
EnterpriseNot statedNot statedNo public price. Demo request only.

Source: vendor pricing page. Last checked November 2, 2026.

What deploys cleanly

Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

Who builds it

Iterative Health (Iterative Health) was founded in 2017 in US, putting it 9 years into market. It was previously known as Iterative Scopes, an acquisition or rebrand that healthcare-AI buyers should track when reviewing prior independent coverage.

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