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Healthtech Startup RNT Health Insights Secures US FDA Breakthrough Designation for Esophageal Cancer Detection Tool

Written by : Nikita Saha

January 9, 2025

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The tool supports gastroenterologists in real-time detection of early and advanced esophageal cancers during standard white-light upper GI endoscopy procedures.

Chandigarh-based healthtech startup RNT Health Insights has received its second US FDA Breakthrough Device Designation for an AI-assisted esophageal cancer detection tool.

The tool supports gastroenterologists in real-time detection of early and advanced esophageal cancers during standard white-light upper GI endoscopy procedures.

Esophageal cancer is the fourth leading cause of cancer-related deaths in India and ranks sixth globally, with over 540,000 annual fatalities. Early detection is critical, as the five-year survival rate can reach 90% when cancers are identified at an early stage. However, up to 25% of pathologies are often missed during routine endoscopic procedures, contributing to a survival rate below 20% for late-stage detection.

RNT Health Insights’ tool is designed to improve early detection rates by aiding in the identification of subtypes such as adenocarcinoma and dysplasia linked to Barrett’s esophagus. It integrates into clinical workflows, offering enhanced diagnostic support while allowing endoscopists to maintain full control over decisions. By increasing the accuracy of early lesion detection and reducing missed cases, the tool aims to improve patient outcomes.

Sharing thoughts, Tanmaya Gulati, Co-founder of RNT Health Insights, said, “This designation not only validates the effectiveness of our technology but also accelerates the pathway to its adoption in clinical settings. Our goal is to ensure that our diagnostic solutions reach as many healthcare providers as possible, enhancing their ability to diagnose and treat gastrointestinal cancers early.”

The FDA Breakthrough Devices Program expedites regulatory review for medical technologies addressing life-threatening conditions. With this second designation, RNT Health Insights strengthens its position, enabling faster access to its technology for clinicians and patients, alongside early feedback from patient advocacy groups and payors.

RNT Health Insights continues to advance AI-assisted diagnostic tools, focusing on improving detection rates, clinical workflows, and patient outcomes in gastrointestinal healthcare.

Stay tuned for more such updates on Digital Health News


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