FDA Radiology AI Devices

The Confocal Microprobe Imaging System by Wuxi Hisky Medical Technologies is a high-resolution optical imaging device used in general and plastic surgery. It helps clinicians obtain detailed images of tissue microstructures during procedures, improving diagnosis and surgical outcomes.

The HyperSnap Surgical System (HSS) is an advanced imaging system used during surgery that combines real-time RGB video with hyperspectral imaging to show tissue oxygen saturation. It uses AI and deep learning to reconstruct images and provide instant feedback to surgeons about tissue health, potentially helping identify tissue ischaemia during open or minimally invasive procedures.

The OPXION Optical Skin Viewer is a non-invasive optical coherence tomography system designed to provide real-time visualization of the external tissues of the human body. It generates two-dimensional, cross-sectional, three-dimensional, and en-face images of tissue microstructures, helping clinicians assess skin conditions with high-resolution imaging.

The Arthrex Synergy Vision Endoscopic Imaging System is an advanced camera system used in endoscopic surgery to provide live imaging in visible and near-infrared light. It helps surgeons visualize vessels, blood flow, lymphatic system, and tissues during minimally invasive surgeries, improving surgical precision and patient outcomes.

The FLUOBEAM LX and FLUOBEAM LM are surgical imaging systems that use near infrared fluorescence to help surgeons visualize blood vessels, tissue perfusion, parathyroid glands, lymphatic vessels, and tissues that have absorbed specific dyes during surgery. By enhancing real-time images of tissues, these devices assist clinicians in making precise assessments during complex surgeries, improving patient outcomes.

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 OPTOVISION Endoscopic Light Source Unit by Optosurgical LLC is a device designed to provide real-time visible and near-infrared fluorescence imaging during endoscopic procedures. Using indocyanine green (ICG) dye, it helps surgeons visualize vessels, blood flow, tissue perfusion, lymphatic systems, and bile ducts to aid minimally invasive surgeries, improving surgical precision and patient outcomes.

The Co-Ablation System with Sterile Co-Ablation Probe is a medical device that freezes and destroys solid tumors and abnormal tissue in various surgical fields using extreme cold temperatures. It is used in open, minimally invasive, or endoscopic procedures to treat cancers, benign tumors, skin lesions, and for pain management by freezing nerve tissue. The system works by delivering liquid nitrogen through a probe to freeze the target tissue under imaging guidance, allowing doctors to visualize the ice ball formation and control the treatment precisely for safer and more effective ablation.

The Edison System is a non-invasive focused ultrasound device designed to mechanically destroy liver tumors using a non-thermal process called histotripsy. Integrated with diagnostic ultrasound imaging, it assists clinicians in precisely targeting and treating liver tumors without surgery, helping to improve liver cancer patient outcomes.

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.