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EchoGo Heart Failure 2.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography. When utilised by an interpreting clinician, this device provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF). EchoGo Heart Failure 2.0 is indicated in adult populations over 25 years of age. Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 2.0 analysis. EchoGo Heart Failure 2.0 takes as input an apical 4-chamber view of the heart that has been captured and assessed to have an ejection fraction ≥50%.

EchoGo Heart Failure 2.0 takes as input a 2D echocardiogram of an apical four chamber tomographic view and reports as output a binary classification suggestive of the presence, or absence of heart failure with preserved ejection fraction (HFpEF). EchoGo Heart Failure 2.0 also provides users with an EchoGo Score ranging from 0 to 100% to support the binary classification. The EchoGo Score informs the binary classification when referenced against the pre-determined decision threshold (50%). To aid in the interpretation of the EchoGo Score, a comparative visual analysis is provided. A histogram format displays the reported EchoGo Score output against a population of patients with known disease status (Independent Testing Dataset). This allows the user to interpret the EchoGo Score relative to the decision threshold of 50%. EchoGo Heart Failure 2.0 should receive an input echocardiogram acquired without contrast and contain at least one full cardiac cycle. EchoGo Heart Failure 2.0 is fully automated and does not comprise a graphical user interface. EchoGo Heart Failure 2.0 is intended to be used by an interpreting clinician as an aid to diagnosis for HFpEF. The ultimate diagnostic decision remains the responsibility of the interpreting clinician using patient presentation, medical history, and the results of available diagnostic tests, one of which may be EchoGo Heart Failure 2.0. EchoGo Heart Failure 2.0 is a prescription only device.

The Vivio® System is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) is above or below 18mmHg. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.

The Vivio System consists of an Arm Cuff system (BP cuff electronics, connection tubinq), EKG patch, and a software application that runs on an off-the-shelf computer tablet. Data is collected non-invasively at the brachial artery and via a single-lead EKG Patch. An off-the-shelf blood pressure arm cuff is attached to the patient's upper arm as if taking a blood pressure measurement. The Arm Cuff is attached to the blood pressure cuff with the quick connect end connected to the pneumatic pump within the Arm Cuff Electronics Enclosure. Two off-the-shelf electrodes are attached to the snap connections on the bottom of the EKG Patch and then connected on the left side of the patient's chest. Both the pneumatic pump attached to the Arm Cuff and EKG Patch are then powered on by pressing and releasing their respective power buttons. The Vivio App is opened on an off-the shelf computer tablet, and the on-screen prompts are followed to connect the Arm Cuff and the EKG Patch. The user is prompted to enter required patient and user data, initiating a patient recording session. Data from the recording session is processed by a proprietary algorithm and results reported on the computer tablet.

EchoGo Heart Failure 1.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography. When utilised by an interpreting clinician, this device provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF). EchoGo Heart Failure 1.0 is indicated in adult populations over 25 years of age. Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 1.0 analysis. EchoGo Heart Failure 1.0 takes as input an apical 4-chamber view of the heart that has been captured and assessed to have an ejection fraction ≥50%.

EchoGo Heart Failure 1.0 is a software-only medical device manufactured by Ultromics Limited and granted breakthrough status by the FDA under Q212613. EchoGo Heart Failure 1.0 takes as input a DICOM file containing an echocardiogram and reports a classification decision suggestive of the presence or absence of heart failure with preserved ejection fraction (HFpEF). The output of this device is based on an artificial intelligence (Al) model developed using a convolutional neural network that produces the classification result. The model takes as input a 2D echocardiogram in which an apical 4-chamber view of the heart has been captured and assessed to have an ejection fraction ≥50% (this would normally be computed using a medical device for the assessment of cardiac function of the left ventricle, for example K213275). The echocardiogram should be acquired without contrast and contain at least one full cardiac cycle. Independent training, validation and test datasets were used for training and performance assessment of the device. EchoGo Heart Failure 1.0 is fully automated and does not comprise a user interface. EchoGo Heart Failure 1.0 produces a report containing the result of the classification, and this report is intended to be used by an interpreting clinician as an aid to diagnosis for HFpEF. The results are intended as an additional input to standard diagnostic pathways and should only be used by an interpreting clinician. The device is a diagnostic aid and thus according to common medical sense and the principles of differential diagnosis any diagnostic finding derived from usage of this product must be confirmed by additional diagnostic investigations, if in doubt. The ultimate diagnostic decision remains the responsibility of the interpreting clinician using patient presentation, medical history, and the results of available diagnostic tests, one of which may be EchoGo Heart Failure 1.0. EchoGo Heart Failure 1.0 is a prescription only device.