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Five cardiologists judged the nurse exams to have sufficient quality to assess left ventricular size in 98.8% of exams, global left ventricular function in 98.8%, right ventricular size in 92.5% and nontrivial pericardial effusion in 98.8%. FDA granted the De Novo request on 7 February 2020. The study had no arm of nurses scanning without guidance, and two of the ten standard views reached diagnostic quality in fewer than 70% of exams.","category":"general benefit","unexpected":false,"purpose":"Caption Guidance was built to help medical professionals, including those without echocardiography training, acquire standard cardiac ultrasound views. The measured benefit is that purpose.","system":"Caption Guidance","model_version":null,"developer":"Caption Health, Inc. 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