Are there any medical image analysis tools that have FDA clearance for clinical decision support?

Yes. There are several medical image analysis tools that have received FDA clearance or authorization and are used for clinical decision support in radiology and related imaging workflows.

A few examples include:

• Aidoc – FDA-cleared AI tools for detecting and prioritizing urgent findings on CT scans, such as intracranial hemorrhage, pulmonary embolism, and cervical spine fractures.
• Viz.ai – FDA-cleared software for detecting large vessel occlusion in stroke imaging and other critical findings, helping clinicians triage patients faster.
• RapidAI – FDA-cleared products for stroke and vascular imaging analysis, including perfusion and occlusion detection.
• Caption Health – FDA-cleared AI-guided ultrasound tools that assist with image acquisition and interpretation support.
• Quantib – FDA-cleared solutions for imaging quantification, including prostate MRI and brain imaging applications.
• Siemens / GE / Philips imaging AI modules – some vendor-integrated tools have FDA-cleared features for lesion detection, quantification, or workflow support.

A few important caveats:

• FDA clearance is specific to the exact indication, workflow, and version of the software.
• Many tools are cleared as software as a medical device (SaMD) for triage, detection, quantification, or workflow prioritization, rather than as a standalone diagnosis.
• “Clinical decision support” can mean different things; in imaging, these tools often support prioritization and interpretation, but the radiologist or clinician remains responsible for the final decision.

If you want, I can also provide:

1. a current list of FDA-cleared imaging AI products,
2. tools by modality (CT, MRI, ultrasound, X-ray), or
3. a brief explanation of how FDA clearance differs from approval.