Authorized purpose: Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.
Which images or clinical context are in scope?Modality: Ultrasound Anatomy or clinical context: Heart/Cardiovascular Input: Multi-frame apical four-chamber cardiac ultrasound images from adults with suspected disease. Validation included routine clinical images from cart-based and portable systems at 1.2-4 MHz.
Who uses it?Intended users: Clinical end users of a legally marketed ultrasound imaging device into which the Strain AI module is integrated.
What does the software produce?Output: A quantitative global longitudinal strain measurement; end users may accept or reject it.
What is its most important limitation?Key limitation: No built-in viewer; integration into a legally marketed ultrasound imaging device is required. Patient management must not rely solely on Strain AI analysis.
Clinical takeaway
Clinical role: Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.
Evidence takeaway
Evidence from the reviewed source record: Regulatory GLS measurement agreement against a reference device; no independent clinical-outcome comparison was established.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.
Multi-frame apical four-chamber cardiac ultrasound images from adults with suspected disease. Validation included routine clinical images from cart-based and portable systems at 1.2-4 MHz.
FDA source
Exact FDA submission
Checked 2026-09-05
The validation frequency range is not a universal compatibility guarantee.
No built-in viewer; integration into a legally marketed ultrasound imaging device is required. Patient management must not rely solely on Strain AI analysis.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
A software module integrated by another programmer into a legally marketed ultrasound imaging device; it uses that device's user interface rather than a built-in viewer.
FDA source
Exact FDA submission
Checked 2026-09-05
The earlier baseline's generic DICOM/PACS claim was not substantiated in this summary. Current Exo Iris interoperability is recorded only as product-family context.
No current security attestation or host-specific retention, access and update architecture was established for SAI001.
Training and support
Vendor documentation pending
Vendor confirmation
Exact product version
Checked 2026-09-05
Host-device onboarding and competency requirements for reviewing or rejecting GLS measurements were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact product version
Checked 2026-09-05
No ongoing quality-monitoring service was established. Editorial site questions: test A4C adequacy, rejected measurements and host software updates.
Current Exo Iris interoperability context
The official Iris specifications list DICOM worklist, store and send and PACS/VNA integration. EHR integration requires Exo Works Enterprise; the listed workflow worksheets and 1 TB cloud storage require Exo Works Connect.
product family ยท checked 2026-09-06
Host-platform package context only; this page does not establish these interfaces for every SAI001 installation.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
Regulatory GLS measurement agreement against a reference device; no independent clinical-outcome comparison was established.
1 unlinked candidate evidence record is retained for source review and excluded from this evidence display.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Research pending
Needs research
Exact product version
Checked 2026-09-05
A priced SAI001 license or public procurement contract was not reviewed; an Exo Iris bundle price would not establish this module's price.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-05
No applicable payer policy content was reviewed for this software or strain service.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: No current security attestation or host-specific retention, access and update architecture was established for SAI001.
Verify training: Host-device onboarding and competency requirements for reviewing or rejecting GLS measurements were not established.
Verify pricing and total cost: A priced SAI001 license or public procurement contract was not reviewed; an Exo Iris bundle price would not establish this module's price.
Verify reimbursement and coding relevance: No applicable payer policy content was reviewed for this software or strain service.
Verify local validation and lifecycle monitoring: No ongoing quality-monitoring service was established. Editorial site questions: test A4C adequacy, rejected measurements and host software updates.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
18Fields reviewed
9Source classes checked
14Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
All 14 stored titles screened and excluded as exact-product evidence: 40055942 is a computer vision syndrome review; the other 13 concern microbiology, microbial strains or veterinary virology. None establishes Exo SAI001 cardiac GLS. No trials were stored. The current discovery snapshot contains 14 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor technical page, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history8 sources - 3 history items
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