Key Features

• Brainomix 360 Stroke automates ASPECTS scoring, ischemic core volume, Net Water Uptake (NWU), and intracranial hemorrhage detection from non-contrast CT (NCCT); adds LVO detection and collateral scoring from CTA; perfusion/mismatch estimation from CTP; and DWI/DWI-FLAIR mismatch and DSC perfusion analysis from MRI (some MRI/CTA sub-features are stated as "CE-mark only," i.e., not currently FDA-cleared for U.S. use).
• The results are typically generated within 1–2 minutes of a scan being sent to the platform, delivered via PACS, email, the Brainomix 360 mobile app, or web browser, and that the platform supports all major scanner and PACS manufacturers via standard DICOM.
• e-Lung is a FDA-cleared AI software that automatically identifies and quantifies features on CT lung scans across multiple timepoints, powered by a proprietary "weighted reticulovascular score" (WRVS) imaging biomarker intended to support earlier assessment in interstitial lung disease, including idiopathic pulmonary fibrosis; independent trade press (Brainomix's own newsroom-hosted release, dated 2026) describes this as the company's first FDA clearance in lung imaging, extending its portfolio beyond stroke.
• The company's flagship stroke product, Brainomix 360 e-ASPECTS, received FDA 510(k) clearance in March 2023; a subsequent 510(k) clearance for its ischemic-core-volume feature from NCCT in April 2025.
• A large real-world study (The Lancet Digital Health, 2025), covering roughly 452,000 patients across 107 hospitals over a five-year period, found Brainomix 360 Stroke was associated with a 100% relative increase in mechanical thrombectomy rates. This is peer-reviewed, independently published research, not only a vendor claim, though the study describes association rather than a randomized controlled proof of causation.
• Brainomix 360 Vantage is a network-level analytics dashboard tracking clinical outcomes (e.g., LVO detections, ASPECTS distribution), clinician engagement/app usage, and operational metrics (processing speed, door-to-groin-puncture timing) across multiple hospital sites.

Compliance & Security

• HIPAA Compliance: Not explicitly stated as "HIPAA compliant" on the vendor's own FAQ (which instead states GDPR compliance and ISO 27001 certification); the vendor does state that patient data is stored on a Brainomix server located inside the hospital itself and is not transmitted externally, with only pseudonymized results sent via email notification, which is a relevant architectural detail for U.S. HIPAA considerations even though the vendor does not use the word "HIPAA" directly in the FAQ reviewed. A buyer in the U.S. should request explicit HIPAA/BAA documentation directly from Brainomix.
• FDA Status: Cleared (510(k)), on a per-product/per-feature basis. Confirmed via the FDA's own clearance letter (K243294, e-ASPECTS) and multiple independent trade-press reports across 2023–2026 covering e-ASPECTS, an ischemic-core-volume feature, and e-Lung. Buyers in the U.S. should confirm which specific modules/features are FDA-cleared versus CE-only before purchasing.
• Security certifications: Brainomix is ISO 27001 certified and GDPR compliant, with a Data Processing Agreement (DPA) available on request.

Integration & Workflow

• The DICOM-based compatibility with "all major scanner and PACS manufacturers," with Brainomix engineers testing all connections prior to go-live.
• Platform: Deployed as a managed appliance on virtualized (cloud) or physical hardware within the hospital with access also available via a native mobile app (iOS and Android) and remotely via existing hospital VPN/Citrix solutions.
• Onboarding/setup: Brainomix engineers handle installation, scanner/PACS connections, protocol setup, and go-live testing in partnership with the hospital's IT team, and that all clinical users receive group training with multilingual user manuals provided post-go-live.

Pricing & Access

• Not publicly listed; the vendor directs prospective customers to "Request a Demo" rather than publishing pricing.

Doxiverse Assessment: Strengths & Limitations

• Strengths: Brainomix has a mature, independently verifiable evidence base for this category. A record of individually confirmed FDA 510(k) clearances since 2023 (verified against the FDA's own clearance letter for e-ASPECTS), a large-scale peer-reviewed real-world study in The Lancet Digital Health covering over 450,000 patients, and a stated 80+ peer-reviewed publication base. The company also has a long operating history for an AI-imaging vendor.
• Limitations/Risks: Several specific Brainomix 360 Stroke sub-features (e.g., CTA collateral scoring, MRI DWI-FLAIR mismatch) are explicitly stated by the vendor as "CE-mark only," meaning U.S. buyers cannot assume full feature parity with the CE-marked European product. The U.S.-available FDA-cleared feature set is narrower. The FDA-cleared e-ASPECTS device's own clearance documentation specifies use with particular scanner models/protocols and explicit exclusions (not for use as a primary diagnostic tool, not for hemorrhagic events, not suitable for motion-artifact-prone patients), underscoring that this is triage/decision-support software with defined intended-use limits rather than a general-purpose diagnostic tool.

Ideal User Profile

• Best for: Comprehensive and primary stroke centers, and stroke networks with hub-and-spoke referral patterns, that want standardized, rapid AI interpretation across NCCT/CTA/CTP/MRI to support transfer and treatment decisions, plus network-wide analytics via Vantage for multi-site stroke systems; also relevant for pulmonology/radiology teams monitoring interstitial lung disease progression via e-Lung.
• Not ideal for: U.S.-based buyers specifically seeking the full CE-marked European feature set (e.g., CTA collateral scoring, DWI-FLAIR mismatch), since these are explicitly not currently FDA-cleared; also less immediately relevant for facilities without CT/MRI stroke-imaging volume or without an interest in acute stroke transfer/treatment-decision workflows.

Disclaimer - This profile was compiled from publicly available sources including the vendor's own website, regulatory filings, press coverage, and independent research. Vendor claims are labeled as such and have not been independently audited by Doxiverse. Product features, pricing, certifications, and regulatory status change frequently and may no longer be current; verify all details directly with the vendor before making a purchasing decision. The "Doxiverse Assessment" and "Ideal User Profile" sections reflect Doxiverse's independent editorial analysis based on available sources at the time of writing, not the vendor's endorsement, and the vendor may disagree with this characterization. This profile is provided for informational purposes only and does not constitute a recommendation, endorsement, or professional/legal/clinical advice. Report inaccuracies to contact@doxiverse.com