NEW YORK – PAVmed subsidiary Lucid Diagnostics announced on Wednesday that its EsoCheck Esophageal Cell Collection Device with Collect+Protect technology has received the CE mark.
The device, which received 510(k) clearance from the US Food and Drug Administration in 2019, is a swallowable balloon capsule catheter that allows a physician to sample surface cells from the esophagus in a noninvasive office procedure.
The procedure takes less than five minutes and allows a sample to be taken in "an anatomically targeted fashion, without sample dilution or contamination," the company said in a statement.
Lucid's device is used with its EsoGuard Esophageal DNA test to act as a screening tool for the early detection of esophageal precancer and cancer in at-risk patients with chronic heartburn. The EsoGuard test has not yet received CE marking, but the company said it expects to complete self-certification "in the very near future." The test received breakthrough device designation from the FDA last year.
Lishan Aklog, Lucid's executive chairman, said in a statement that the company will be proceeding with a commercial launch in select European countries in the near future.