FDA Radiology AI Devices

The CEREGLIDE 42 and 57 Intermediate Catheters, together with the Cerenovus Aspiration Tubing Set, are medical devices used to remove blood clots from large intracranial vessels during acute ischemic strokes. These catheters are navigated through the brain's blood vessels under fluoroscopic imaging to restore blood flow by aspirating clots, helping patients who cannot receive or have failed drug-based clot dissolving treatments.

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 SPECTRALIS with Flex Module is an advanced eye imaging device designed for non-contact visualization of the posterior segment and vasculature of the retina and choroid in adults and pediatric patients, including those in supine (lying down) position. It helps ophthalmologists detect and monitor various eye conditions by providing high-quality images of eye structures, enabling improved diagnosis and management.

EchoMeasure by iCardio.ai is an AI-powered software that analyzes previously acquired cardiac ultrasound images to automatically measure key cardiac anatomical parameters. It assists cardiologists and healthcare professionals by providing accurate measurements for clinical decision-making, enhancing efficiency and supporting diagnostic review.

The EPIQ Series Diagnostic Ultrasound System by Philips is an advanced ultrasound imaging device that uses AI-powered software to aid clinicians in semi-automated quantification of heart valve function, specifically assessing the tricuspid valve and mitral valve regurgitation. This helps improve accuracy and efficiency in diagnosing cardiac conditions by providing detailed measurements and flow analysis from 3D ultrasound images.

Lunit INSIGHT DBT v1.1 is an AI-powered software designed to assist physicians in detecting and characterizing suspicious breast lesions in digital breast tomosynthesis exams. It marks regions of potential cancer with abnormality scores to aid diagnosis, improving clinical workflow for breast cancer screening in women.

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.

Encevis (2.1) is a software tool that assists neurologists by automatically analyzing EEG recordings to detect seizures, spikes, electrographic status epilepticus, and other brain activity patterns. It reduces artifacts in EEG data, provides quantitative measures like frequency bands and burst suppression, and displays alerts to support rapid clinical decision-making, especially in acute care settings.

PIUR tUS Infinity is a computer-aided detection system that assists medical professionals by analyzing ultrasound images of the thyroid and thyroid nodules. It uses AI and machine learning algorithms to create 3D volume reconstructions from 2D ultrasound images, allowing quantification and visualization of thyroid nodules to aid diagnosis. The system integrates seamlessly with FDA-cleared ultrasound equipment and produces reports to support clinical decisions.

CINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.