Author: Yoman

[Medical ML] EU Experience: CE-Marked Diagnostic AI

Posted on by Yoman
Medical Research
Medical Research by Oleh Ivchenko  ·  DOI: 10.5281/zenodo.18752882  

Ukraine's regulatory trajectory aligns with the EU Medical Device Regulation (MDR) through ongoing European integration reforms. Understanding the European CE marking process—with its emphasis on clinical evidence and post-market surveillance—directly informs how Ukrainian hospitals should evaluate AI diagnostic tools.

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Medical Research by Oleh Ivchenko DOI: 10.5281/zenodo.18752882
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[Medical ML] US Experience: FDA-Approved AI Devices

Posted on by Yoman
Medical Research
Medical Research by Oleh Ivchenko  ·  DOI: 10.5281/zenodo.18752886  75stabilfr·wdophcgmx
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[l]Academic100%✓≥80% from journals/conferences/preprints
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[d]DOI [REQ]✓✓Zenodo DOI registered for persistent citation. DOI: 10.5281/zenodo.18752886
[o]ORCID [REQ]✓✓Author ORCID verified for academic identity
[p]Peer Reviewed [REQ]—✗Peer reviewed by an assigned reviewer
[h]Freshness [REQ]100%✓≥60% of references from 2025–2026. Current: 100%
[c]Data Charts0○Original data charts from reproducible analysis (min 2). Current: 0
[g]Code—○Source code available on GitHub
[m]Diagrams4✓Mermaid architecture/flow diagrams. Current: 4
[x]Cited by0○Referenced by 0 other hub article(s)
Score = Ref Trust (91 × 60%) + Required (3/5 × 30%) + Optional (1/4 × 10%)

As Ukraine develops its regulatory framework for medical AI (aligned with EU MDR through recent reforms), understanding the world's largest medical AI market provides invaluable lessons. The US FDA has authorized over 1,200 AI/ML-enabled medical devices—more than any other regulatory body—making it the de facto testing ground for medical AI deployment.

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Medical Research by Oleh Ivchenko DOI: 10.5281/zenodo.18752886 75stabilfr·wdophcgmx
BadgeMetricValueStatusDescription
[s]Reviewed Sources0%○≥80% from editorially reviewed sources
[t]Trusted100%✓≥80% from verified, high-quality sources
[a]DOI100%✓≥80% have a Digital Object Identifier
[b]CrossRef0%○≥80% indexed in CrossRef
[i]Indexed100%✓≥80% have metadata indexed
[l]Academic100%✓≥80% from journals/conferences/preprints
[f]Free Access100%✓≥80% are freely accessible
[r]References1 refs○Minimum 10 references required
[w]Words [REQ]1,099✗Minimum 2,000 words for a full research article. Current: 1,099
[d]DOI [REQ]✓✓Zenodo DOI registered for persistent citation. DOI: 10.5281/zenodo.18752886
[o]ORCID [REQ]✓✓Author ORCID verified for academic identity
[p]Peer Reviewed [REQ]—✗Peer reviewed by an assigned reviewer
[h]Freshness [REQ]100%✓≥60% of references from 2025–2026. Current: 100%
[c]Data Charts0○Original data charts from reproducible analysis (min 2). Current: 0
[g]Code—○Source code available on GitHub
[m]Diagrams4✓Mermaid architecture/flow diagrams. Current: 4
[x]Cited by0○Referenced by 0 other hub article(s)
Score = Ref Trust (91 × 60%) + Required (3/5 × 30%) + Optional (1/4 × 10%)
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[Medical ML] Regulatory Landscape for Medical AI: FDA, CE Marking, and Ukrainian MHSU

Posted on by Yoman
Medical Research
Medical Research by Oleh Ivchenko  ·  DOI: 10.5281/zenodo.18752890  

For ScanLab and any medical AI initiative targeting Ukrainian healthcare, regulatory compliance isn't optional—it's existential. Understanding the regulatory landscape determines:

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Medical Research by Oleh Ivchenko DOI: 10.5281/zenodo.18752890
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