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Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test
2021/10/07

Cairn Diagnostics, an established firm providing cutting-edge breath tests intended for routine use in diagnostic medicine, has announced that the U.S. Food and Drug Administration (FDA) has expanded its approval of the company’s 13C-Spirulina Gastric Emptying Breath Test (GEBT) to now include “at home” administration under the virtual supervision of Cairn Diagnostics.

 

GEBT is an FDA-PMA approved, CE marked, Class III in-vitro diagnostic drug-medical device combination product used for measuring the rate of solid phase gastric emptying and identifying delayed gastric emptying, a condition known as gastroparesis, in patients ages 18 years and older. This innovative breath test is non-invasive, orally administered, and standardized. It does not involve any radioactive material and does not require nuclear medicine imaging equipment, specially licensed facilities or personnel.

Conducted over a 4-hour period after an overnight fast, the GEBT is a simple process, designed to show how quickly the stomach empties solids by measuring labeled carbon dioxide in a patient’s breath. The physician receives a comprehensive gastric emptying report via a secure portal within 24-48 hours after receipt of patient breath samples.

 

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Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test

Source: GEBT