RNT Health Insights receives second US FDA breakthrough device designation for Esophageal Cancer detection tool

 

RNT Health Insights, a Chandigarh-based health-tech startup specializing in AI-assisted diagnostic solutions for the accurate detection of pathologies during endoscopic procedures, has been granted its second US FDA Breakthrough Device Designation for its Esophageal Cancer detection tool. This tool aids gastroenterologists in the real-time detection and identification of early-stage and advanced esophageal cancers during standard white-light upper GI endoscopy procedures.

RNT Health Insights is leading the way in the early detection of Gastrointestinal cancers through cutting-edge AI technology and facilitating timely intervention.

“Receiving this second breakthrough designation from the FDA marks a significant milestone in our journey to transform gastroenterological diagnostics. It propels us forward, enabling quicker integration of our cutting-edge technologies into clinical practice, which is vital for saving lives through early detection, said Ria Khurana, Co-founder of RNT Health Insights.

Esophageal cancer is the fourth leading cause of cancer-related deaths in India, and the sixth leading cause of cancer-related deaths worldwide, claiming over 540,000 lives annually. Its prognosis is notably poor, with a five-year survival rate of less than 20%. This is primarily due to the associated high miss rate of detection during early stages and attributed to the fact that it is almost always detected at an advanced stage.

The second US FDA Breakthrough Device Designation recognition highlights RNT Health Insights’ dedication to advancing the field of gastrointestinal diagnostics through the development of innovative solutions, catering to more accurate detection of early-stage pathologies.

RNT Health Insights’ tool effectively aids in detecting subtypes such as adenocarcinoma, and dysplasia associated with Barrett's esophagus. While not intended to replace clinical decision-making, this technology integrates into existing clinical workflows, ensuring endoscopists can maintain full control over decision-making while benefiting from enhanced diagnostic support. This tool intends to greatly improve the accuracy of detection of early-stage lesions, reducing the missed detection rate thereby significantly improving patient outcomes.

Tanmaya Gulati, Co-founder of RNT Health Insights, added, “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 US FDA Breakthrough Devices Program fosters the development of innovative medical technologies that address life-threatening or debilitating conditions by providing expedited regulatory review and development pathways. Already a part of the program for its Early Gastric Cancer detection technology, RNT Health Insights has now strengthened its position with a second inclusion for its esophageal cancer detection technology. This designation provides prioritized interaction with the FDA and streamlined approval processes, enabling faster access to groundbreaking diagnostic tools for clinicians and patients alike. With this designation, the company intends to accelerate timelines for approval and market access and gain access to early feedback and support from patient advocacy groups and payor organizations for early coverage.

Research underscores that early and accurate detection significantly improves survival outcomes; in some cases, the 5-year prognosis can improve to 90%. Despite advances in endoscopic technologies, early-stage detection of esophageal cancer is challenging, with studies indicating that up to 25% of esophageal cancer-related pathologies may be missed during routine endoscopic procedures.