FDA Radiology AI Devices

The EyeBOX EBX-4.1 is an eye-tracking device designed to help diagnose concussions by measuring eye movements. It uses a high-speed infrared camera to record gaze while the patient watches a video stimulus. The device automatically analyzes the data and produces a BOX score indicating the likelihood of concussion, comparing the eye tracking metrics to a normative database of uninjured individuals. This helps clinicians assess brain injury more objectively and quickly.

Philips VSC-MEDlib is a software library intended to automatically and contactlessly measure respiration rate by analyzing video streams of a patient's torso during virtual consults or health screenings. It uses camera-captured images to detect torso motion and calculate breathing frequency, providing clinicians with an additional vital sign measurement to support patient assessment. It is designed for use in clinical or home environments under healthcare professional supervision.

RayStation and RayPlan are advanced software systems designed for radiation therapy planning and medical oncology. They help clinicians propose and optimize treatment plans based on patient imaging data, improving the delivery of safe and effective radiation doses. The software supports a range of radiotherapy techniques, including photon and proton therapies, and incorporates sophisticated dose calculation and optimization algorithms to tailor treatments to individual patients' needs.

The WHOOP ECG (electrocardiogram) Feature is a mobile application software used with the WHOOP Strap wearable device to record and analyze a single-channel ECG signal similar to a Lead I ECG. It helps users detect atrial fibrillation, normal sinus rhythm, and abnormal heart rates by providing informational ECG data and rhythm classification, aiding users and clinicians in heart rhythm monitoring without replacing traditional diagnosis methods.

Masimo W1 is a wearable watch device that continuously records, displays, and transfers single-channel ECG rhythms and pulse oximetry parameters. It includes software for automated classification of atrial fibrillation to aid in heart rhythm identification, designed for adults in clinical and home settings to support healthcare professionals and patients in monitoring heart conditions.

The Nurochek-Pro System is a portable EEG-based device that generates visual evoked potentials to help healthcare professionals diagnose mild traumatic brain injury (mTBI) in patients aged 12 to 44. Worn on the patient's head, it records brain electrical activity and provides an analytic aid to detect mTBI within 5 days after a potential head injury, improving diagnostic accuracy in clinical settings.

SnapshotGLO is a handheld, point-of-care imaging device that helps clinicians visualize and document skin wounds using autofluorescence technology. It captures images of wounds under excitation light to highlight areas with bacterial presence, enhancing wound assessment alongside clinical signs and symptoms. It is intended as an adjunct tool to aid in wound diagnosis and monitoring but does not itself diagnose or treat wounds.

The ARVIS Surgical Navigation System assists surgeons during orthopedic surgeries by providing real-time, augmented reality-based visualization and precise intraoperative measurements to aid in positioning and aligning implants. It enhances surgical accuracy in procedures such as knee and hip arthroplasties, improving outcomes and helping surgeons make informed decisions during operations.

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 Starlight Imaging Catheter is a sterile, single-use catheter designed for imaging coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light and an internal rotating fiber optic core to capture detailed cross-sectional images inside vessels, helping clinicians assess vessel condition and guide interventions safely and effectively.