Echo IQ Ltd. disclosed that the FDA issued a not substantially equivalent determination for its initial 510(k) submission for Echosolv HF, an AI-based heart failure clinical decision support software. The ruling delays U.S. commercial clearance. The update highlights a persistent hurdle for digital health developers: achieving equivalence on technical and performance characteristics under traditional regulatory comparisons, especially for AI-driven decision support. For biotech-adjacent diagnostics teams, it underscores why regulatory strategy and evidence packages—training data documentation, validation across sites, and performance reproducibility—remain critical when software advances from research pilots to market-facing systems.