PAVmed Inc. (the “Company” or “PAVmed”), a highly differentiated, multi-product medical device company, today announced that its majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), has received 510(k) marketing clearance for its EsoCheck Cell Collection Device™ (“EsoCheck”) from the U.S. Food and Drug Administration (FDA).
EsoCheck is a non-invasive cell collection device that is designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure, without the need for endoscopy. The patient swallows a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs the target area for a sample of cells and protects that sample from contamination as the device is removed. The sampled cells can then be subjected to any commercially available diagnostic test. FDA determined that EsoCheck is substantially equivalent to legally marketed predicate devices for its indications for use, namely “the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age or older”.