FDA Grants 510(k) Clearance for Lucid Diagnostics to Market EsoCheck
By MedTech Outlook | Monday, July 15, 2019
The incorporation of EsoCheck will enable diagnostics clinics to enhance the treatment of patients suffering from esophageal diseases.
FREMONT, CA: Lucid Diagnostics recently received a 510(k) marketing clearance for EsoCheck Cell Collection Device from the Food and Drug Administration (FDA). The device is a giant step toward improving the treatment of patients suffering from gastroesophageal reflux disease and Barrett’s Esophagus, and might even lead to the successful prevention of esophageal cancer.
Lucid Diagnostics has several years of expertise in the field and possesses extensive knowledge regarding the critical advances in the industry. EsoCheck can be leveraged to sample cells from specific regions in the esophagus. Its ability to identify esophageal anomalies can potentially save the lives of people suffering from esophageal diseases. The offering by Lucid Diagnostics is one of the many products designed to fulfill the unmet clinical needs of the industry. The company seeks to increase its engagements with clinical innovators and leading academic medical centers.
EsoCheck, the non-invasive cell collection device, samples cells from targeted areas in the esophagus in a five-minute procedure without the need for endoscopy. The patient is made to swallow a vitamin pill-sized capsule containing a tiny inflatable balloon attached to a thin catheter. When the catheter is withdrawn, it swabs the targeted area, gathering the sample of cells and securing it from contamination.
The sampled cells can be subjected to a commercially available diagnostic test. EsoCheck is equivalent to legally marketed predicate devices for its indication of use. Its primary objective lies in collecting and retrieving surface cells from the esophagus in the general population of adults.
The clearance by FDA came one year after the day Lucid was founded, and EsoCheck was licensed from Case Western Reserve University. It will not be long before Lucid Diagnostics makes the groundbreaking technology available for physicians and patients. EsoCheck will be a significant improvement from the conventional sponge-on-a-string esophageal cell collection devices leveraged today.
The conventional devices use a capsule which needs to be digested in the stomach before using it for sample collection. However, with EsoCheck, the physicians can begin sampling immediately after insertion. The EsoCheck’s Collect+Protect technology enables it to conduct targeted sampling of the lower esophagus, unlike the spherical sponge-on-a-string devices which sample cells from the entire esophagus, throat, and mouth which can lead to dilution and contamination of the lower esophageal cells.