FDA approved AI tools

 two AI-based tools related to liver disease that have received regulatory milestones by the U.S. Food and Drug Administration (FDA). Note: the list is small because few liver-AI tools have full diagnostic clearance yet.

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1. AIM‑NASH (by PathAI)

• This is a cloud-based AI system that analyses digital images of liver biopsy histology to score features like steatosis (fat infiltration), lobular inflammation, ballooning and fibrosis according to the NASH Clinical Research Network scoring system. (U.S. Food and Drug Administration)

• The FDA qualified AIM-NASH as a Drug Development Tool (DDT) for use in clinical trials of Metabolic Dysfunction‑Associated Steatohepatitis (MASH) / formerly NASH. (U.S. Food and Drug Administration)

• Important limitations: This qualification does not indicate clearance/approval for standalone diagnostic use in routine clinical practice. A pathologist must still review and approve the results. (Fierce Biotech)

• Intended context: clinical trial endpoints and histology scoring standardisation. (pharmaphorum)

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2. Velacur ONE (by Sonic Incytes Medical Corp.)

• This is a point-of-care ultrasound elastography device with AI-guided features, intended to assess liver stiffness (fibrosis), attenuation (fat), and a proprietary fat fraction metric (VDFF) for management of chronic liver disease (including MASLD/MASH). (DI Europe)

• The FDA granted 510(k) clearance to the Velacur ONE for features supporting liver disease assessment. (DI Europe)

• This tool is more in the imaging/point-of-care device side, rather than purely software-AI histology scoring.

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Summary Table

Tool	Regulatory Status	Purpose/Use Case	Key Notes
AIM-NASH	FDA qualified as DDT	Histology scoring in MASH drug trials	Not cleared for general clinical diagnosis
Velacur ONE	FDA 510(k) clearance	POC ultrasound elastography for liver disease	Device + AI guidance, non-biopsy mode

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