India-based clinical-stage medical diagnostics company RNT Health Insights has received breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its early gastric cancer detection tool.
During routine endoscopy procedures, this technology is designed to detect in real-time any lesions found in the upper gastrointestinal tract indicative of early gastric cancer, as well as gastric malignancy, including gastric atrophy, nodules, polyps, masses and growths present in the stomach.
Gastric cancer ranks as the fourth most deadly cancer worldwide, with a five-year survival rate below 40%.
Early detection is crucial, as it can significantly increase the survival rate to 90%.
Traditional endoscopic methods for diagnosing gastric cancer have a variable miss rate of 4.6%-25.8%, influenced by the endoscopist's experience and visual assessment.
The early gastric cancer detection tool developed by RNT Health Insights is claimed to have a 96% accuracy rate, as demonstrated in preclinical validation.
The FDA BDD is granted to medical devices that come with reasonable clinical proof to provide major advancements representing breakthrough technology in either diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions, with approved alternatives currently not available, and therefore their availability is in the interest of patients.
This BDD will facilitate a faster review process, potentially expediting the availability of this technology to healthcare providers and patients.
Established in 2022, RNT Health Insights is focused on incorporating advanced technology into real-time diagnostic procedures in endoscopy.
The company's flagship project targets the early detection of gastric pathologies, using a vast collection of endoscopic images and videos to refine diagnostic precision and enhance patient care.
