RNT Health Insights Receives Second US FDA Breakthrough Device Designation for Esophageal Cancer Detection Tool

Chandigarh-based health-tech startup RNT Health Insights has achieved a significant milestone by receiving its second US FDA Breakthrough Device Designation. This recognition is for its innovative Esophageal Cancer detection tool, designed to assist gastroenterologists in real-time identification of early-stage 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 fatalities annually. Its prognosis remains dire, with a five-year survival rate of less than 20 per cent due to late-stage diagnoses and a high miss rate during early stages. Research demonstrates that early detection can dramatically improve survival outcomes, raising the five-year survival rate to as high as 90 per cent. However, studies reveal that up to 25 per cent of esophageal cancer pathologies are overlooked during routine endoscopic procedures, underscoring the need for advanced diagnostic tools.

This second US FDA Breakthrough Device Designation underscores RNT Health Insights’ commitment to transforming gastrointestinal diagnostics through cutting-edge technology. The tool is specifically designed to enhance the detection of early-stage lesions and subtypes like adenocarcinoma and dysplasia associated with Barrett's esophagus. While ensuring clinicians retain full decision-making control, it integrates seamlessly into clinical workflows, reducing missed diagnoses and significantly improving patient outcomes.  

Tanmaya Gulati, Co-founder of RNT Health Insights, highlighted the importance of this achievement: “This designation not only validates the effectiveness of our technology but also accelerates its adoption in clinical settings. Our goal is to empower healthcare providers with tools to diagnose and treat gastrointestinal cancers at an early stage, ultimately saving lives.”

The US FDA Breakthrough Devices Program aims to expedite the development and approval of innovative medical technologies addressing life-threatening conditions. Already part of this program for its Early Gastric Cancer detection technology, RNT Health Insights has further solidified its position with this second recognition. The designation facilitates prioritized FDA interactions, streamlined approval processes, and early collaboration with payor organizations and patient advocacy groups to enable broader market access and coverage.

Ria Khurana, Co-founder of RNT Health Insights, remarked: “Receiving this second breakthrough designation from the FDA is a pivotal moment in our mission to revolutionize gastroenterological diagnostics. It ensures our technologies reach clinical practice faster, improving early detection rates and saving lives.”