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Home » Lucid Diagnostics Earns 510(K) Clearance for Esophageal Cell Collector
Lucid Diagnostics Earns 510(K) Clearance for Esophageal Cell Collector
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The FDA granted PavMed subsidiary Lucid Diagnostics 510(k) clearance for its EsoCheck product, a device that collects cells from the esophagus without the need for endoscopy.
The device is used in a non-invasive office procedure that takes about five minutes to collect cells from a patient’s esophagus.
EsoCheck serves as an alternative to current sponge-on-a-string devices used to gather esophageal cells, which require patients to digest a capsule before sampling.
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