Chandigarh-based health-tech startup RNT Health Insights, specialising in AI-assisted diagnostic solutions, has received its second US FDA Breakthrough Device Designation for its esophageal cancer detection tool. The tool assists gastroenterologists in real-time detection and identification of early and advanced esophageal cancers during standard white-light upper GI endoscopy procedures.
Esophageal cancer ranks as the fourth leading cause of cancer-related deaths in India and the sixth globally, with over 540,000 annual fatalities. Its prognosis remains poor, with a five-year survival rate below 20 per cent, largely due to delayed detection. Early-stage identification significantly improves survival outcomes, with research indicating that early and accurate detection can elevate the five-year survival rate to 90 per cent. However, early detection is challenging, as studies show up to 25 per cent of pathologies are missed during routine endoscopic procedures.
The second breakthrough designation underscores RNT Health Insights’ efforts to enhance gastrointestinal diagnostics. The tool aids in detecting subtypes like adenocarcinoma and dysplasia linked to Barrett’s esophagus. It integrates seamlessly into clinical workflows, supporting endoscopists with enhanced diagnostic capabilities while ensuring they retain full decision-making control. By improving the accuracy of early-stage lesion detection and reducing missed cases, the technology aims to improve patient outcomes.
“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,” said Tanmaya Gulati, Co-founder of RNT Health Insights.
The FDA Breakthrough Devices Program supports innovative medical technologies addressing life-threatening or debilitating conditions by providing expedited regulatory review. RNT Health Insights, already a participant in the program for its early gastric cancer detection technology, has strengthened its position with this second designation. This status provides expedited approval processes, enabling faster access to the technology for clinicians and patients, as well as early feedback from patient advocacy groups and payor organisations.
“Receiving this second breakthrough designation from the FDA marks a significant milestone in our journey to transform gastroenterological diagnostics,” said Ria Khurana, Co-founder of RNT Health Insights. “It propels us forward, enabling quicker integration of our cutting-edge technologies into clinical practice, which is vital for saving lives through early detection.”
RNT Health Insights continues to drive innovation in the field of AI-assisted diagnostic tools, with the aim of improving detection rates, clinical workflows, and patient outcomes in gastrointestinal healthcare.