Preemptive receives FDA 510(k) clearance

February 13, 2026 Measure Labs, Inc. (DBA PreemptiveAI, Inc.) Matt Whitehill Chief Technology Officer 2790 Mosside Blvd. Monroeville, Pennsylvania 15146 Re: K250233 Trade/Device Name: PreemptiveAI Clinical SDK Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH Dated: February 10, 2026 Received: February 11, 2026 Dear Matt Whitehill: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Sincerely, Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health