Acorai Machine Learning Generalization (MLG) Study

"A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.~No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital.~A single follow-up observational data collection will be conducted at 90 days, to collect the number of unplanned hospitalizations since the procedure visit. This does not involve active patient participation."

"A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.~No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital."