Authorized purpose: Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter editing in compatible DICOM integration environments; it does not alter original images or replace diagnosis.
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: Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter editing in compatible DICOM integration environments; it does not alter original images or replace diagnosis.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter editing in compatible DICOM integration environments; it does not alter original images or replace diagnosis.
Which images or clinical context are in scope?Modality: MRI Anatomy or clinical context: Brain Input: Multiphase or monophase neurological MR images in DICOM, including FLAIR, T1, T2, T1g, diffusion (DWI), and DSC perfusion series.
Who uses it?Intended users: Appropriately trained medical professionals analyzing neurological MRI
What does the software produce?Output: Parametric maps and metrics including ADC, CBF, CBV, corrected CBV, K2, MTT, TTP, Tmax/Delay, and tMIP, plus intra- and inter-exam co-registration and optional viewing/comparison through Neuro Synchronizer.
What is its most important limitation?Key limitation: The device does not alter original medical images, is not a standalone diagnostic device, and should not be the sole basis for patient-management decisions; users remain responsible for full-image review and professional judgment.
Clinical takeaway
Clinical role: Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter editing in compatible DICOM integration environments; it does not alter original images or replace diagnosis.
Evidence takeaway
Evidence from the reviewed source record: The FDA packet describes brain-extraction module validation on 362 manually annotated MR volumes across five-fold cross-validation; this is a submodule evaluation, not an end-to-end clinical outcome study of Neuro Insight.
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
Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter editing in compatible DICOM integration environments; it does not alter original images or replace diagnosis.
Parametric maps and metrics including ADC, CBF, CBV, corrected CBV, K2, MTT, TTP, Tmax/Delay, and tMIP, plus intra- and inter-exam co-registration and optional viewing/comparison through Neuro Synchronizer.
The device does not alter original medical images, is not a standalone diagnostic device, and should not be the sole basis for patient-management decisions; users remain responsible for full-image review and professional judgment.
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
NeuroPro can be integrated and deployed through a technical integration environment responsible for transferring, storing, converting, and displaying DICOM data; Neuro Synchronizer can be integrated with compatible environments.
No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Current onboarding, competency, and support commitments were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Local acceptance testing, production monitoring, update control, and drift review were not established.
DICOM integration environment
The exact submission describes NeuroPro integration with an environment that transfers, stores, converts, and displays DICOM imaging data, with optional Neuro Synchronizer viewing and parameter editing.
Olea's official Neuro INSIGHT page describes web-based access without installation on the reading station and standard PACS/RIS integrations; the current deployed configuration and exact submission build require confirmation.
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
The FDA packet describes brain-extraction module validation on 362 manually annotated MR volumes across five-fold cross-validation; this is a submodule evaluation, not an end-to-end clinical outcome study of Neuro Insight.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
No public amount, range, currency, geography, or contract term was established.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
No payer or CMS policy review was performed in this worker cohort.
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 care setting and population: Confirm the intended care setting, patient population, and service line.
Verify security and privacy controls: No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
Verify training: Current onboarding, competency, and support commitments were not established.
Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, update control, and drift review were not established.
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
2026-09-07Last searched
23Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen is not a full paper review. The current discovery snapshot contains 0 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 product page, literature index, trial registry, fda device recall, 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 history7 sources - 3 history items
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