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Us2.ca processes acquired transthoracic cardiac ultrasound images to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in their diagnosis of cardiac amyloidosis. Us2.ca is intended for use only in adult patients with increased left ventricular wall thickness, defined as an interventricular septal thickness (IVSd) or left ventricular posterior wall thickness (LVPWd) ≥ 12mm. Us2.ca is not intended to provide a diagnosis and does not replace current standards of care. The results from Us2.ca are not intended to exclude the need for further follow-up on cardiac amyloidosis.

The Us2.ai platform is a clinical decision support tool that analyzes echocardiogram images in order to generate a series of AI-derived measurements. Fully automated, functional reporting with disease indications is also provided, in line with ASE & ESC guidelines. Echo images are sent to the Us2.ai platform where they are processed, analyzed and measured. Results that meet the confidence threshold for both image quality and measurement accuracy are passed through to a report for review by the clinical users. Report text is also generated and presented with the measurements, providing functional reporting and disease indications. The ultimate clinical decision and interpretation reside solely with the clinician. Us2.ca is an enhancement to Us2.ai existing Us2.v2 software, adding the capability to detect cardiac amyloidosis. It is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images in DICOM format. The device is intended to aid diagnostic review and analysis of echocardiographic data, patient record management and reporting. The primary intended function of Us2.ca is to automatically identify patients who require additional follow-up for cardiac amyloidosis. In doing so, the primary benefit is to improve clinical echocardiographic workflow, enabling clinicians to generate and edit reports faster, with precision and with full control. The final clinical decision of the results still remains with the clinicians.

InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography. When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.

The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm to identify high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos. The device assists clinicians in the diagnosis of cardiac amyloidosis. The InVision PCA algorithm uses a machine learning process to identify the presence of cardiac amyloidosis. The device inputs images and videos from echocardiogram studies, and it outputs a report suggestive or not suggestive of cardiac amyloidosis. The device has no physical form and is installed as a third-party application to an institution's PACS system.

The Etiometry Platform™ software features the Data Aggregation software module version 5.4 and the Risk Analytics Engine software module version 9.2. The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: To remotely consult regarding a patient's status and To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. The Data Aggregation & Visualization software module can display numeric physiologic data and waveforms captured by other medical devices: Airway flow, volume, and pressure Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) Bispectral index (BIS, signal quality index, suppression ratio) Cardiac Index Cardiac output Central venous pressure Cerebral perfusion pressure End-tidal CO2 Heart rate Heart rate variability Intracranial pressure Left atrium pressure Oxygen saturation (intravascular, regional, SpO2) Premature ventricular counted beats Pulmonary artery pressure (systolic, diastolic, and mean) Pulse pressure variation Pulse Rate Respiratory rate Right atrium pressure Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) Umbilical arterial pressure (systolic, diastolic, and mean) Electrocardiogram Plethysmograph The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module. The Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia. The IDO2 Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery, and attention should be brought to the patient. The IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. The IVCO2 Index is indicated for use by healthcare professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the IVCO2 Index is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation, and attention should be brought to the patient. The IVCO2 Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The ACD Index is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the ACD Index is increasing, it means that there is an increasing risk of acidemia, and attention should be brought to the patient. The ACD Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The HLA Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation software module. When the HLA Index is increasing, it means that there is an increasing risk of hyperlactatemia, and attention should be brought to the patient. The HLA Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Etiometry Platform allows ICU clinicians and quality improvement teams to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. The platform features include: - Adjunctive status indicators - Customizable display of physiologic parameters over the entire patient stay - Configurable annotation - . Web-based visualization that may be used on any standard browser - Minimal IT footprint - . Software-only solution – no new bedside hardware required - . Highly reliable and robust operation - . Auditable data storage

EchoGo Amyloidosis 1.0 is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over with heart failure undergoing cardiovascular assessment using echocardiography. When utilised by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. EchoGo Amyloidosis 1.0 is indicated in adult patients aged 65 years and over with heart failure. Patient management decisions should not be made solely on the results of the EchoGo Amyloidosis 1.0 analysis.

EchoGo Amyloidosis 1.0 takes a 2D echocardiogram of an apical four chamber (A4C) as its input and reports as an output a binary classification decision suggestive of the presence of Cardiac Amyloidosis (CA). The binary classification decision is derived from an AI algorithm developed using a convolutional neural network that was pre-trained on a large dataset of cases and controls. The A4C echocardiogram should be acquired without contrast and contain at least one full cardiac cycle. Independent training, tune and test datasets were used for training and performance assessment of the device. EchoGo Amyloidosis 1.0 is fully automated without a graphical user interface. 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 Amyloidosis 1.0. EchoGo Amyloidosis 1.0 is a prescription only device.

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.

Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.

Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia based on quantitative measures of atherosclerosis, stenosis, and significant vascular morphology from typically-acquired Coronary Computed Tomography Angiography images (CCTA). Cleerly ISCHEMIA, in conjunction with Cleerly Labs, outputs a Cleerly ISCHEMIA Index (CII), a binary indication of negative CII (likely absence of ischemia) or positive CII (likely presence of ischemia) with its threshold equivalent to invasive FFR >0.80 vs. ≤0.80, respectively, as identified in professional societal practice guidelines.

The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 9.0. The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices: - · Airway flow, volume, and pressure - · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) . - Cardiac Index - Cardiac output . - Central venous pressure . - . Cerebral perfusion pressure - End-tidal CO2 . - · Heart rate - Heart rate variability . - Intracranial pressure . - . Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) . - Premature ventricular counted beats . - Pulmonary artery pressure (systolic, diastolic, and mean) . - Pulse pressure variation - · Pulse Rate - · Respiratory rate - Right atrium pressure . - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module. The T3 Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia. The IDO2 Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. The IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The ACD Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the ACD Index™ is increasing, it means that there is an increasing risk of acidemia and attention should be brought to the patient. The ACD Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The HLA Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the HLA Index™ is increasing, it means that there is an increasing risk of hyperlactatemia and attention should be brought to the patient. The HLA Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include: - Adjunctive status indicators ● - Customizable display of physiologic parameters over the entire patient stay - . Configurable annotation - Web-based visualization that may be used on any standard browser - Minimal IT footprint ● - Software-only solution no new bedside hardware required ● - Highly reliable and robust operation - . Auditable data storage

The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0. The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: - . To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in . clinical decisions and deliver patient care in a timely manner. The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices: - · Airway flow, volume, and pressure - · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - · Bispectral index (BIS, signal quality index, suppression ratio) - · Cardiac Index - . Cardiac output - Central venous pressure . - . Cerebral perfusion pressure - · End-tidal CO2 - · Heart rate - · Heart rate variability - Intracranial pressure . - . Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) . - · Premature ventricular counted beats - · Pulmonary artery pressure (systolic, diastolic, and mean) - · Pulse pressure variation - · Pulse Rate - · Respiratory rate - · Right atrium pressure - · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. The T3 Data Aggregation & Visualization software module can display information captured by the T3 Adult Risk Analytics Engine software module. The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of madequate oxygen delivery and attention should be brought to the patient. The Adult IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include: - · Customizable display of physiologic parameters over entire patient stay - Configurable annotation - Web-based visualization that may be used on any standard browser - Minimal IT footprint - Software-only solution no new bedside hardware required - Highly reliable and robust operation - Auditable data storage

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.