NexusAI solutions are validated across real-world clinical environments, with peer-reviewed publications and outcome data that demonstrate measurable impact on patient care and health system performance.
Every NexusAI solution is designed around the clinical workflow it serves — from acute imaging triage to end-to-end care coordination across disease pathways.
NexusAI's platform is built on methodologies and clinical AI approaches with a robust body of peer-reviewed literature, multi-center trials, and real-world outcome studies.
We believe clinical AI should be held to the highest standards of safety, efficacy, and transparency. Here is our current regulatory position.
NexusAI's clinical AI algorithms are not yet FDA 510(k) cleared or CE-marked. They are deployed under research use agreements and quality improvement frameworks at partner institutions, with all outputs classified as clinical decision support tools requiring clinician review and approval.
We are pursuing FDA 510(k) clearance for our core imaging AI algorithms under the Software as a Medical Device (SaMD) framework. Our validation studies are designed and statistically powered to meet FDA's performance benchmarks for Computer-Aided Detection (CADe) and Computer-Aided Diagnosis (CADx) devices.
Our algorithms are validated through prospective and retrospective studies using de-identified patient data under IRB-approved protocols. Validation datasets span multiple institutions, patient demographics, imaging vendors, and scanner generations to ensure generalizability and equity.
All NexusAI AI outputs are presented as decision support — not autonomous diagnostic systems. Clinicians retain full interpretive authority. We proactively disclose model limitations, demographic performance variation, and confidence thresholds in every deployment. Continuous post-market performance monitoring is built into the platform.
We are concurrently pursuing CE marking under the EU Medical Device Regulation (MDR) and UKCA certification for our imaging AI algorithms. International validation cohorts are included in our study design to support multi-jurisdictional submissions.
We will not commercialize clinical AI algorithms for diagnostic use without appropriate regulatory clearance or approval. Our regulatory transparency page is updated regularly as submissions progress. Questions about our regulatory program can be directed to our clinical affairs team.
We partner with leading health systems to conduct rigorous validation studies and co-develop the clinical evidence base for next-generation healthcare AI.