FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

ClearPoint System (Software Version 2.2) is a medical software device designed to assist clinicians during neurological procedures by providing MRI-guided stereotactic guidance for the placement and operation of instruments like biopsy needles or deep brain stimulation leads. It integrates advanced automatic segmentation and visualization of brain structures from MRI scans, enhancing planning and intraoperative navigation. This helps improve surgical accuracy and patient outcomes in brain interventions.

FDA #
K233243
Product Code
HAW
Page 1 of 11 results
1

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.