HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-B…

HoneyNaps' SOMNUM V3.0 AI software for sleep apnea diagnosis has received FDA 510(k) clearance, automatically classifying obstructive, central, and mixed sleep apnea subtypes with 97%+ accuracy. The clearance expands the company's regulatory footprint in clinical sleep diagnostics and signals a pathway for future digital biomarker approvals. You can now sell AI diagnostic software directly into sleep labs without proving equivalence to a predicate device—HoneyNaps has cracked the FDA pathway, and the 97% accuracy bar is now the market entry requirement for your competitors in this segment. The next move is selling to hospital systems that already have polysomnography infrastructure but can't hire enough technicians to score the data.