Vivante Health Announces Study Findings To Support The Clinical Validation Of The GIMate
Vivante Health, the leading digital solution for digestive health and disease, announced study findings to support the clinical validation of their novel handheld breath testing device, the GIMate. The clinical trial, performed by Duke University, found that the GIMate was 100% as accurate in diagnosing lactose malabsorption in a head-to-head comparison with a previously FDA cleared device for the same clinical indication.
“We are grateful for our partners at Duke University who executed this study, and are thrilled by the published results, which highlight the incredible clinical performance of the GIMate in diagnosing a common GI condition,” Vivante Health’s Chief Medical Officer Simon Mathews, MD said.
The study showed technical performance metrics of 100% positive percent agreement (PPA) and 100% negative percent agreement (NPA). The study included 31 participants with prior history of lactose malabsorption or suspected lactose intolerance. The study was published online in the leading peer-reviewed digital health journal, JMIR Formative Research. A link to the findings in the study can be found here.
“These findings support the clinical foundation of the GIMate and will help us launch a broad range of potential novel clinical applications to support our members with their digestive health,” Vivante Health’s CEO Bill Snyder shared. Vivante Health is planning to apply the findings to help symptomatic individuals without a diagnosis as well as those with common diagnoses such as Irritable Bowel Syndrome.
The GIMate is the latest addition to the GIThrive program that helps members who suffer from digestive conditions and symptoms.
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