FDA clears EsoCheck device

The FDA has given 510(k) clearance to the EsoCheck Cell Collection Device, according to a press release from the manufacturer, Lucid Diagnostics.

Amitabh Chak, MD, of Case Western Reserve University School of Medicine, said the device allows for non-invasive collection of cells from targeted areas of the esophagus using a small inflatable encapsulated balloon attached to a small catheter. The device protects the sampled cells inside the capsule as it is withdrawn, helping to avoid contamination.