FDA Radiology AI Devices

The Philips Holter Analysis System is a standalone software designed to analyze ambulatory ECG recordings collected over extended periods (typically 24 hours to 7 days). It automatically processes ECG data to detect heart rhythm disturbances, arrhythmias, pacemaker function, and myocardial ischemia-related symptoms, providing reports to assist clinicians in evaluating cardiac health. The system enhances arrhythmia detection algorithms and heart rate variability analysis and integrates with clinical information systems for streamlined ECG data management.

The FlowTriever2 Catheter is a medical device designed for the non-surgical removal of blood clots (emboli and thrombi) from peripheral blood vessels, particularly for the treatment of pulmonary embolism. It uses fluoroscopic visualization aided by radiopaque markers to guide the device through blood vessels, capturing and extracting clots to restore normal blood flow. This device helps clinicians perform thrombectomy procedures with precision, facilitating minimally invasive treatment of embolic conditions in peripheral and pulmonary vasculature.

Loss of Pulse Detection is a software application from Fitbit designed to analyze pulse data collected by consumer wrist-worn devices to detect possible loss of pulse events. When such events are detected, it alerts the user with audio, visual, and haptic signals, and can prompt an emergency call if the user does not respond. This helps in early identification of critical cardiac events, improving patient safety by notifying potential emergencies.

PanopticAI Vital Signs is a medical software application that uses AI algorithms to measure pulse rate non-invasively by analyzing color changes in facial video captured from an iPhone or iPad camera. It helps healthcare professionals monitor a patient's pulse rate remotely, providing a convenient tool to complement traditional vital sign assessments.

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.

The Artix™ MT and Artix™ Thin-Walled Thrombectomy Sheath are devices designed to remove clots non-surgically from peripheral blood vessels. They facilitate catheter insertion and vascular access, allowing for mechanical thrombectomy and thrombus aspiration, which assists clinicians in restoring blood flow during vascular interventions.

The ShortCut device by Pi-Cardia Ltd. is a single-use catheter designed to safely split bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures in patients at risk of coronary obstruction. This catheter-based tool is inserted via the femoral artery and positions its distal cutting element on valve leaflets to perform precise cuts, helping improve blood flow and reduce complications during transcatheter valve replacement procedures. It has been demonstrated in clinical studies to be effective and safe, providing a new treatment option for high-risk patients undergoing valve-in-valve procedures.

HeartKey Rhythm is a software platform designed to analyze ECG data from various ambulatory monitoring devices such as Holters and ECG patches. Using a combination of machine learning and signal processing, the software detects heartbeats, assesses rhythm, and identifies arrhythmias to assist healthcare professionals in diagnosing cardiac conditions. It integrates through an API into other ECG management or monitoring systems and supports non-urgent clinical decision making.

The FaceHeart Vitals Software Development Kit (FH vitals SDK) is an AI-based software that measures pulse rate from facial video streams using standard cameras on mobile devices or computers. It provides non-invasive, real-time pulse rate monitoring for adults at rest, intended to assist healthcare professionals but not to replace critical care or continuous monitoring. The SDK uses face recognition and signal processing algorithms to produce accurate pulse rate measurements, helping clinicians monitor patient heart rate remotely or in general healthcare settings.