Hologic Genius AI vs Ultromics EchoGo

Ultromics EchoGo works on transthoracic echocardiography. Its heart failure tool (K222463, then version 2.0 as K240013 decided September 23, 2024) is a diagnostic aid for HFpEF on an apical four-chamber view in adults over 25 with an ejection fraction of 50% or higher. Its amyloidosis screen (K240860, decided November 15, 2024) targets adults 65 and older with heart failure. Ultromics states 90.3% sensitivity and 86.1% specificity for the heart failure tool, citing K240013. A 2026 JACC Heart Failure analysis in the MESA cohort (N=2,544) reported AUROC 0.77 for EchoGo HF against 0.70 for H2FPEF in early HFpEF. Hologic's Genius AI Detection 2.0 (K243341, decided July 31, 2025) is the newest record, the Genius AI Detection 2.0 product page lists a Case Complexity Index and a Read Time Indicator for tomosynthesis reading, and K230096 (May 23, 2023) added automated CC and MLO lesion correlation. Hologic's press release describes an MGH study of 7,500 screening exams in which the AI flagged about a third of cancers read negative at first read. The two read different studies, transthoracic echo for a cardiology service and breast tomosynthesis for a breast imaging service.