NEW YORK (360Dx) — Lucid Diagnostics has received 510(k) clearance from the US Food and Drug Administration for its EsoCheck Cell Collection Device, the company's parent firm PavMed said today.
EsoCheck uses a balloon catheter to collect cells from a targeted region of the esophagus without the need for endoscopy. Collected cells can then be analyzed with a commercially available test. New York City-based Lucid is also developing a methylated DNA biomarker test for Barrett's esophagus — called EsoCheck Dx — that uses samples collected with EsoCheck.
"We are proud to have received FDA clearance for EsoCheck just over one year from the day we founded Lucid and licensed this groundbreaking technology from Case Western Reserve University," PavMed Chairman and CEO Lishan Aklog said in a statement. "We look forward to offering EsoCheck to physicians and patients this summer and believe EsoCheck presents many advantages over existing sponge-on-a-string esophageal cell collection devices."