The FDA’s GenAI-device paper is a question set, not a compliance checklist
FDA is considering a competency-based evaluation model for generative-AI medical devices. Its discussion paper offers diligence questions about the finished device, intended use, clinical confirmation, and postmarket monitoring—not adopted requirements.
Super Genius Labs Editorial · Aug 23, 2026 · 4 min readEngineeringA two-plane worksheet for agent operating systems—and an explicit infrastructure boundary
A two-plane worksheet helps platform teams separate governance decisions from runtime coordination, then make deployment context and infrastructure ownership reviewable at every boundary.
Super Genius Labs Editorial · Aug 18, 2026 · 3 min readThinkingWhat evidence should healthcare AI operators retain for non-device software?
FDA’s patient-safety inquiry gives healthcare AI operators a bounded prompt: preserve intended use, observed benefits, safety signals, implementation lessons, governance practices, and evidence ownership without treating an operational record as a legal classification or proof of safety.
Super Genius Labs Editorial · Aug 13, 2026 · 4 min readThinkingRead Cortex AI Gateway as an announced control plane—not a verified operating result
Snowflake has announced one control layer for agent access, activity records, interoperability, and AI spending. Preview status leaves its behavior, coverage, and enforcement open to operator verification.
Super Genius Labs Editorial · Aug 11, 2026 · 3 min read