Swallowable Device to Detect Pre-cancerous Barrett's Esophagus Receives FDA 510(k) Clearance (IMAGE)

Case Western Reserve University

Swallowable Device to Detect Pre-cancerous Barrett's Esophagus Receives FDA 510(k) Clearance

Caption

Investigators developed the test for early detection of Barrett's esophagus that offers promise for preventing deaths from esophageal adenocarcinoma. The test involves a novel swallowable balloon device that samples the esophagus and a DNA assay that detects Barrett's esophagus and esophageal cancers. In a major step to bringing this technology forward to patients, the balloon device has just received 510K clearance from the U.S. Food and Drug Administration (FDA) for clinical use. The now FDA-cleared device is being manufactured by Lucid Diagnostics and marketed under the tradename EsoCheck.

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Case Western Reserve University School of Medicine

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