RNT Health Insights Private Limited receives FDA designation as a breakthrough device for early detection of gastric cancer

RNT Health Insights Private Limited, a clinical-stage medical diagnostics company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its early detection tool for gastric cancer. Their innovative solution aims to detect changes occurring in the upper gastrointestinal tract, indicating early gastric cancer, as well as gastric cancers, including gastric atrophy, nodules, polyps, tumors and growths occurring in the stomach, in real time during a standard endoscopy exams.

FDA Breakthrough Device Designation is awarded to medical devices that have substantiated clinical evidence that offer significant advances that constitute a breakthrough technology in the diagnosis or treatment of a life-threatening or irreversibly debilitating disease or condition, with no available approved alternatives, and their availability is at the highest level of patient interest. The program aims to provide patients and healthcare providers with rapid access to medical devices by accelerating development, evaluation and review for pre-market approval and marketing authorization. Benefits of the program include accelerating device development, prioritizing subsequent regulatory filings, and potentially providing faster refunds once cleared through customs.

Stomach cancer is the fourth leading cause of cancer-related deaths worldwide, with a five-year survival rate of less than 40%. However, there are reports that early accurate detection of stomach cancer can increase the 5-year survival rate to 90%. Although gastrointestinal endoscopic procedures are the gold standard in the diagnosis of this disease, the current failure rate in diagnosing gastric cancer during these procedures is 4.6–25.8%, depending on the endoscopists’ experience and visual observations. RNT Health Insights’ gastric cancer early detection technology can be used in real time during endoscopic procedures to detect these pathologies, and currently has a detection accuracy of 96%, according to preclinical validation. With the breakthrough device designation, RNT Health Insights will benefit from an expedited review pathway to obtain the necessary approvals to bring its device to market. The company anticipates this will accelerate the timetable for bringing the innovative tool to market, ultimately benefiting patients and healthcare providers.