FDA Radiology AI Devices

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

DermaSensor is a handheld device combined with a base unit that uses optical spectroscopy and an AI/machine learning algorithm to analyze suspicious skin lesions and assist physicians, especially those not trained as dermatologists, in deciding whether a patient should be referred to a dermatologist. It provides a classification indicating whether to monitor the lesion or investigate further, helping clinicians detect common skin cancers earlier and more accurately.

The SurgiCount+ System by Stryker Instruments is a multifunctional software application designed to assist clinicians in estimating blood loss during surgery by analyzing images of used surgical sponges. It uses AI algorithms to estimate hemoglobin mass and blood volume on sponges and incorporates RFID technology to count and locate surgical sponges, improving surgical item management and patient safety.

autoSCORE is a software tool that assists neurologists by automatically analyzing EEG recordings to identify and categorize abnormal brain activity such as epileptiform and non-epileptiform abnormalities. It acts as a decision support system, marking potential abnormal areas on EEG data, thereby helping clinicians review EEGs more efficiently and accurately. The device does not provide final diagnostic conclusions but rather supports professional judgment in interpreting EEG results.

The REMI AI Discrete Detection Module (REMI-AI DDM) is a software tool designed to assist physicians qualified in EEG interpretation by automatically identifying and marking sections of EEG recordings that may correspond to seizure-like events. It processes previously acquired EEG data collected via the REMI Remote EEG Monitoring System, helping speed up and improve the review process for EEG data in patients aged 6 years and older. The software does not provide diagnostic conclusions but serves as an aid to clinicians in seizure detection support.

ART-Plan is a radiotherapy treatment planning software that assists clinicians by visualizing and fusing multimodal medical images, automatically segmenting organs and lymph nodes using AI, generating synthetic CT images from MR and CBCT scans, computing dose distributions for radiation therapy, and aiding in treatment adaptation decisions. It enhances workflow efficiency and accuracy for trained professionals managing radiotherapy for cancer patients.

uOmnispace.MI is an advanced software platform designed to help healthcare professionals view and analyze medical images from PET, CT, MR, and SPECT scans. It facilitates tasks such as image registration, lesion segmentation, and statistical analysis, supporting clinical workflows in oncology, neurology, and cardiology. The software integrates multiple applications including fusion imaging, dynamic analysis, brain scan quantification, and cardiac function analysis, thereby assisting clinicians in making timely and accurate diagnoses.

The EW10-EC02 Endoscopy Support Program is an AI-driven software tool designed to support endoscopists by detecting colon polyps and adenomas in real time during standard colonoscopy exams. It processes real-time endoscopic video images from White Light Imaging and Linked Color Imaging to highlight potential lesions, helping clinicians improve diagnosis and patient outcomes without replacing clinical judgment.

Tyto Insights for Wheeze Detection is an AI-powered software tool that analyzes lung sounds recorded by the FDA-cleared Tyto Stethoscope to automatically detect the presence of wheezing. This helps clinicians by providing decision support in respiratory assessments for adults and children aged 2 years and older. It offers clear positive or negative wheeze detection results through a web interface accessible to healthcare providers and patients, improving remote and point-of-care lung sound evaluation.

Syngo Carbon Clinicals is a software package that provides advanced visualization tools to help healthcare professionals prepare, measure, and analyze medical images from modalities such as CT and MRI. It supports manipulation and communication of clinical data, enabling qualitative and quantitative assessment to assist in diagnosis and treatment planning.