Radiology Solutions
FDA-cleared AI solutions for radiology triage and critical case prioritization
Company profile
Company profile
mlHealth 360 is a global healthtech company founded in 2023 and headquartered in Surrey, British Columbia, Canada. The company is transforming radiology through secure, FDA-cleared AI solutions that go beyond simple image screening to provide a comprehensive intelligence layer for modern hospitals. By leveraging deep learning technology, mlHealth 360 enables healthcare professionals to triage critical cases in seconds, prioritizing urgent care while reducing diagnostic costs and dramatically improving patient outcomes. The company builds human-led AI that turns the complexity of radiology into clear, actionable insights for clinicians. With offices in both Canada and India, mlHealth 360 serves health systems and hospitals globally, focusing on optimizing clinical decision-making through advanced AI-enabled healthcare solutions. The company actively contributes to health innovation ecosystems by working with health authorities, researchers, and academic institutions to safely pilot and validate technology that can scale globally.
Company description Mlhealth 360 official website
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01 · Operating footprint
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Cloud Saas deployment with recorded integration context.
Company milestones
Participated in Mayor's Forum on Health Care and Innovation in Surrey (2024), representing the company in building health innovation ecosystem discussions
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02 · Flagship portfolio
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FDA-cleared AI solutions for radiology triage and critical case prioritization
03 · Research intelligence
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Research
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Clinical validation
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Regulatory
K250694 · 510k · Nov 25, 2025
04 · Company-reported outcomes
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Enables rapid prioritization of urgent care
Through AI-enabled optimization of radiology workflows
Through faster identification and prioritization of critical cases
05 · Leadership
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06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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