FDA 510(k) AI

AI‑driven diagnostics in SaaS is moving from single‑use algorithms to integrated, cloud platforms that deliver FDA‑cleared detections, workflow‑embedded insights, and care coordination across radiology, pathology, cardiology, and primary care in near real time. Health systems are standardizing on imaging suites and AI networks to scale models, govern performance, and reduce time‑to‑diagnosis while protecting PHI and clinical oversight. … Read more