RNT Health Insights Receives FDA Breakthrough Device Designation for Gastric Cancer Detection Tool

The new detection tool aims to identify various gastric malignancies, including gastric atrophy, nodules, polyps, masses, and other growths in the stomach.

RNT Health Insights, a clinical-stage medical diagnostics startup based in Chandigarh, has received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its early Gastric Cancer detection tool.

This advanced technology is designed to detect lesions indicative of early gastric cancer in real-time during routine endoscopy procedures.

The new detection tool aims to identify various gastric malignancies, including gastric atrophy, nodules, polyps, masses, and other growths in the stomach.

Gastric cancer is the fourth leading cause of cancer-related mortality globally, with a five-year survival rate of less than 40%. Early and accurate detection, however, can increase the five-year survival rate to 90%.

Despite gastrointestinal endoscopic procedures being the gold standard for diagnosing gastric cancer, the current miss rate for detecting gastric cancers during these procedures ranges from 4.6% to 25.8%, depending on the endoscopist's experience and visual observations.

RNT Health Insights claims their early gastric cancer detection tool has demonstrated a 96% accuracy rate in preclinical validation, significantly improving the potential for early detection.

Breakthrough Device Designation

The FDA's Breakthrough Device Designation is granted to medical devices that provide substantial improvements over existing technologies in the diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.

This designation facilitates a faster review process, potentially expediting the availability of innovative technologies to healthcare providers and patients.

Established in 2022, RNT Health Insights focuses on integrating advanced technology into real-time diagnostic procedures in endoscopy.

The startup's flagship project aims to detect gastric pathologies early. It leverages a vast collection of endoscopic images and videos to refine diagnostic precision and enhance patient care.

The BDD will provide RNT Health Insights with an expedited review pathway, accelerating the process of obtaining necessary permits to market their device. This will ultimately benefit patients and healthcare providers by making this advanced detection tool available sooner.

Early detection of gastric cancer is crucial as it significantly improves the survival rates. With the new detection tool, endoscopists will have a higher chance of identifying malignancies at an early stage, allowing for timely and effective treatment.

This technological advancement is expected to reduce the miss rate in endoscopic procedures, providing a more reliable diagnostic method.

The FDA's Breakthrough Device Designation marks a significant milestone for the startup.

As the startup moves towards bringing its tool to market, it anticipates that the expedited review process will help in swiftly making this life-saving technology available to the medical community.

In a similar development, Mumbai-based healthtech startup Qure.ai also received the 'Breakthrough Device' designation from the FDA Center for Devices and Radiological Health (CDRH) for its AI-powered tuberculosis (TB) solution, qSpot-TB.

The AI-powered qSpot-TB is a second-read computer-aided detection and diagnosis device that analyzes chest X-rays to localize all noted radiological signs suggestive of TB. Further, based on these findings, the device generates a report indicating the presence or absence of TB.