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The BrightHeart View Classifier device is intended to analyze fetal 2D ultrasound images and video clips using machine learning techniques to automatically detect standard views during fetal heart scanning. The BrightHeart View Classifier device is intended to be used as an adjunct to the acquisition and interpretation of fetal anatomic ultrasound examinations at the second or third trimester of pregnancy performed with transabdominal probes.

BrightHeart View Classifier is a cloud-based software-only device which uses artificial intelligence (AI) to detect standard views during fetal heart scanning in fetal ultrasound images and video clips. BrightHeart View Classifier is intended to be used by qualified, trained healthcare professional personnel in a professional prenatal ultrasound (US) imaging environment (this includes sonographers, MFMs, OB/GYN, and Fetal surgeons), to help fetal ultrasound examination acquisition and interpretation of 2D grayscale ultrasound by providing automatic classification of video clips and images into standard views, by automatically extracting example frames of standard views from video clips, and by automatically assessing whether the documentation of each standard view in video clips and images satisfies an acquisition protocol defined by the center. Annotated DICOM files generated by the device cannot be modified by the user.

The BrightHeart View Classifier device is intended to analyze fetal 2D ultrasound images and video clips using machine learning techniques to automatically detect standard views during fetal heart scanning. The BrightHeart View Classifier device is intended to be used as an adjunct to the acquisition and interpretation of fetal anatomic ultrasound examinations at the second or third trimester of pregnancy performed with transabdominal probes.

BrightHeart View Classifier is a cloud-based software-only device which uses artificial intelligence (AI) to detect standard views during fetal heart scanning in fetal ultrasound images and video clips. BrightHeart View Classifier is intended to be used by qualified, trained healthcare professional personnel in a professional prenatal ultrasound (US) imaging environment (this includes sonographers, MFMs, OB/GYN, and Fetal surgeons), to help fetal ultrasound examination acquisition and interpretation of 2D grayscale ultrasound by providing automatic classification of video clips and images into standard views, by automatically extracting example frames of standard views from video clips, and by automatically assessing whether the documentation of each standard view in video clips and images satisfies an acquisition protocol defined by the center. Annotated DICOM files generated by the device cannot be modified by the user.

Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: - overriding artery - septal defect at the cardiac crux - abnormal relationship of the outflow tracts - enlarged cardiothoracic ratio - right ventricular to left ventricular size discrepancy - tricuspid valve to mitral valve annular size discrepancy - pulmonary valve to aortic valve annular size discrepancy - cardiac axis deviation Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views. Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams. Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: - overriding artery - septal defect at the cardiac crux - abnormal relationship of the outflow tracts - enlarged cardiothoracic ratio - right ventricular to left ventricular size discrepancy - tricuspid valve to mitral valve annular size discrepancy - pulmonary valve to aortic valve annular size discrepancy - cardiac axis deviation Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views. Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams. Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy, and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.