FDA-cleared profile
EXINI Diagnostics AB
aBSI marks lesions and quantifies skeletal disease burden on nuclear-medicine bone scans as a fraction of total skeletal weight for trained professionals and researchers.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Confirm the controls against the exact contracted architecture and release.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K191262 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Cloud service accessed through a personal login on Windows or macOS Chrome, with image upload from a local or network folder; validate DICOM transfer, identity, patient matching, longitudinal alignment, browser support, and result export.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. aBSI is quantitative decision support, not a standalone metastasis diagnosis. Threshold-dependent staging performance can trade sensitivity against specificity, and scan counts, acquisition speed, urinary activity, protocol, and disease burden can affect results.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: aBSI is quantitative decision support, not a standalone metastasis diagnosis. Threshold-dependent staging performance can trade sensitivity against specificity, and scan counts, acquisition speed, urinary activity, protocol, and disease burden can affect results.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.
Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.
Association of baseline aBSI with outcomes in aBSI.
Tested version: aBSI version 3.4 cleared in K191262Overall survival per aBSI relationship in aBSI.
Tested version: aBSI version 3.4 cleared in K191262Multivariable overall survival in aBSI.
Tested version: aBSI version 3.4 cleared in K191262aBSI increase of 0.6 and radiographic progression in aBSI.
Tested version: aBSI version 3.4 cleared in K191262Simulated BSI from 0.10 to 13.0 in aBSI.
Tested version: EXINI bone BSI version 2Automated change interpretation in aBSI.
Tested version: EXINI bone BSI version 2Metastasis classification against available reference in aBSI.
Tested version: EXINI Bone version 1.6.2Metastasis classification against available reference in aBSI.
Tested version: EXINI Bone version 1.6.2Manufacturer analytical validation plus prospective planned phase III and retrospective clinical-outcome analyses · Men with metastatic castration-resistant prostate cancer
exact submission · Tested version: aBSI version 3.4 cleared in K191262 · n=721 · 241 sites · Sponsor or vendor studyK191262
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Independent analytic simulation, repeat-scan, and follow-up agreement studies · Simulated bone scans and patients with metastatic prostate cancer
product family · Tested version: EXINI bone BSI version 2; not exact aBSI 3.4 · n=173 · Independent studyPMC4975929
Algorithm-family evidence with an earlier version; includes a documented bladder-region blind spot.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 10 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, peer reviewed publication, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
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