FDA Radiology AI Devices

The Falcon/Xpress is a compact, portable ultrasonic diagnostic device designed for the noninvasive evaluation of peripheral vascular conditions. It uses pneumatic pressure measurements, Doppler ultrasound, and photo-plethysmography to assess blood flow and vascular health in various limb sites. This helps clinicians diagnose vascular diseases and monitor vascular function with specialized testing protocols.

Laminar P1 is a wearable and disposable ultrasound patch sensor designed to detect blood flow in peripheral vessels to help identify peripheral vascular disease. It is intended for use by healthcare professionals in various settings and offers a compact alternative to traditional Doppler ultrasound probes, providing audio output and selectable sensitivity settings to aid clinical assessments.

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

EchoGo Heart Failure 2.0 is an AI-powered software tool that analyzes echocardiogram images of the heart's apical four-chamber view to support clinicians in detecting heart failure with preserved ejection fraction (HFpEF). It provides a diagnostic aid by outputting a classification and a confidence score, enhancing cardiovascular assessments and helping guide clinical decision-making.