HeartFocus (V.1.1.1)

The HeartFocus software is an AI-powered radiological computer-assisted system designed to guide medical professionals in acquiring diagnostic-quality transthoracic echocardiography images. Through real-time probe manipulation guidance and automated image detection, it enables users without prior sonography training to successfully perform cardiac ultrasound exams, validated by a multicentric clinical study demonstrating high image quality endpoints.

The HeartFocus software (V.1.1.1) is designed as a radiological computer-assisted acquisition guidance system that aids medical professionals in capturing cardiac ultrasound images. It functions as an accessory to compatible general-purpose diagnostic ultrasound systems, providing real-time user guidance for acquiring ten specific two-dimensional transthoracic echocardiography (2D-TTE) views in adult patients. Utilizing artificial intelligence, the software offers live guidance for probe manipulation, detects diagnostic-quality images, enables automatic recording of high-quality clips, and allows for retrospective saving of the best acquired clips. Its capabilities are comparable to existing guidance systems designed for similar purposes.Rigorous human factors validation and AI algorithm performance testing confirmed the system's safety and effectiveness. A multicentric clinical study demonstrated that medical professionals without prior echocardiography training could successfully acquire cardiac ultrasound exams of sufficient quality for key clinical assessments, with primary image quality endpoints consistently achieving 100%. The study also showed high rates of diagnostic-quality clip acquisition for all standard views across diverse patient populations. To ensure ongoing quality and allow for future enhancements, a Predetermined Change Control Plan outlines protocols for managing updates, such as expanding compatibility with new ultrasound and operating systems, by specifying retraining and re-validation procedures.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific AI algorithms are utilized by the HeartFocus software for real-time guidance and image quality detection, and how were they trained and validated?; Beyond image acquisition, does the HeartFocus system offer any post-processing capabilities or integration with EMR systems for more comprehensive patient data management?; How does the HeartFocus software's performance compare to expert sonographers in terms of scan time, diagnostic accuracy, and inter-operator variability across various patient pathologies?; What were the specific patient demographics and clinical conditions included in the multicentric clinical study, and were there any limitations or subgroups where the software's performance was less optimal?; What are the planned future enhancements under the Predetermined Change Control Plan, particularly regarding expansion to other cardiac imaging modalities or advanced diagnostic features?