Device For Detecting Pre-Cancerous Barrett’s Esophagus Receives FDA Clearance

Device For Detecting Pre-Cancerous Barrett’s Esophagus Receives FDA Clearance

Device For Detecting Pre-Cancerous Barrett's Esophagus

The test involves a 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 device is being manufactured by Lucid Diagnostics and marketed under the tradename EsoCheck.

Sourced through Scoop.it from: www.mpo-mag.com

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Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.

Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.

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