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A cardiologist confirmed each label by review of the chart and any imaging. The software had a sensitivity of 68.4% and a specificity of 99.1%. At a disease prevalence of 0.2%, its positive predictive value was 13.7%. FDA granted the De Novo request on 3 August 2023 and found that the probable benefits outweigh the probable risks. The reviewers write that the benefit is added detection of a disease that is uncommon and difficult to diagnose. The study used historical records, so the software did not guide care, and it missed about one in three patients with the disease.","category":"general benefit","unexpected":false,"purpose":"Viz HCM was built to detect signs of hypertrophic cardiomyopathy on 12-lead ECGs and identify patients for follow-up. 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