MARCH 27, 2024

FDA Clears Magnetic Balloon System to Aid Endoscopy

The FDA has granted 510(k) clearance to Endorail (Endostart), a magnetic balloon system designed to help resolve intestinal looping and improve colonoscopy quality.

The system, which is now commercially available in the United States, consists of a single-use balloon catheter and a reusable handpiece containing a magnet. To resolve intestinal looping, the catheter can be inserted into a colonoscope’s tool channel and then filled with the company’s ferromagnetic fluid, which is