National, January 7, 2025 – RNT Health Insights, a Chandigarh-based health-tech startup specializing in AI-assisted diagnostic solutions, has secured its second US FDA Breakthrough Device Designation for its Esophageal Cancer detection tool. This innovative tool supports 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 worldwide, with over 540,000 fatalities annually. The prognosis is dire, with a five-year survival rate of less than 20%, primarily due to late detection. Early and accurate detection can dramatically improve survival rates, with some cases reaching up to 90%. Despite advancements in endoscopic technologies, early-stage esophageal cancer often goes undetected, with studies showing up to 25% of related pathologies are missed during routine procedures.
This second US FDA Breakthrough Device Designation underscores RNT Health Insights’ commitment to enhancing gastrointestinal diagnostics through innovative solutions aimed at more accurate early-stage pathology detection. The tool effectively identifies subtypes such as adenocarcinoma and dysplasia linked to Barrett’s esophagus. While it doesn’t replace clinical decision-making, it integrates seamlessly into existing workflows, enhancing diagnostic accuracy without compromising endoscopists’ control over their decisions.
Tanmaya Gulati, Co-founder of RNT Health Insights, stated, “This designation validates our technology’s effectiveness and accelerates its adoption in clinical settings. Our goal is to extend our diagnostic solutions to as many healthcare providers as possible, improving early diagnosis and treatment of gastrointestinal cancers.”
The US FDA Breakthrough Devices Program supports the development of medical technologies addressing life-threatening conditions by offering expedited review and development pathways. Already part of the program for its Early Gastric Cancer detection tool, RNT Health Insights has reinforced its position with this new designation for esophageal cancer detection. This recognition ensures prioritized FDA interactions, streamlined approval processes, and faster market access, benefiting clinicians and patients with groundbreaking diagnostic tools.
“Receiving this second breakthrough designation from the FDA is a significant milestone in transforming gastroenterological diagnostics,” said Ria Khurana, Co-founder of RNT Health Insights. “It accelerates the integration of our cutting-edge technologies into clinical practice, vital for saving lives through early detection.”
