FDA Clears Persyst 15 EEG Review Software
The FDA cleared Persyst Development's Persyst 15 EEG Review and Analysis Software on October 31, 2025, finding it substantially equivalent under submission number K252160 through the traditional 510(k) pathway. The agency classifies it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. The category covers software that automatically flags events within full-montage EEG recordings for clinician review.
Why it matters
Automatic event detection is the layer where EEG reading is actually being automated, and each clearance in the category fixes the regulatory baseline that later detection algorithms will be measured against.