Lucid Diagnostics Earns 510(K) Clearance for Esophageal Cell Collector

The FDA granted PavMed subsidiary Lucid Diagnostics 510(k) clearance for its EsoCheck product, a device that collects cells from the esophagus without the need for endoscopy.

The device is used in a non-invasive office procedure that takes about five minutes to collect cells from a patient’s esophagus.

EsoCheck serves as an alternative to current sponge-on-a-string devices used to gather esophageal cells, which require patients to digest a capsule before sampling.