PreemptiveAI Clinical SDK

PreemptiveAI Clinical SDK is an FDA 510(k)-cleared medical device (K250233) manufactured by Measure Labs, Inc. (Dba Preemptiveai, Inc.). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2026. Regulation: 8.