Echo IQ disclosed the FDA issued a not substantially equivalent determination for its AI heart failure clinical decision support software, Echosolv HF, delaying US commercialization tied to its initial 510(k). The setback emphasizes that even when the product aims to assist clinical workflows, equivalence standards still determine market access. Meanwhile, a separate validated hospital deployment reported nearly 91% sensitivity and 99.65% accuracy for an automated acute kidney injury alert system with decision support across a 2,768-bed real-world setting. The performance metrics highlight what regulators and clinicians typically want: reproducibility in operational environments, not just algorithm accuracy in offline testing. For developers of clinical AI, the contrast illustrates the difference between clearance blockers and systems that have already demonstrated performance in real deployment conditions.