India-based RNT Health Insights has received breakthrough device designation from the US Food and Drug Administration (FDA) for its early gastric cancer detection tool.
The artificial intelligence (AI)-assisted tool is designed to identify lesions in the upper gastrointestinal tract that signal early gastric cancer.
It also detects various gastric malignancies such as gastric atrophy, nodules, polyps, masses, and growths within the stomach.
According to RNT Health Insights, its early gastric cancer detection technology is capable of real-time detection during endoscopic procedures.
It uses a large dataset of endoscopy images and videos to improve diagnostic accuracy.
The tool intends to support endoscopists in improving patient outcomes by facilitating timely intervention and reducing missed diagnoses.
During preclinical testing, the early gastric cancer detection tool has shown a 96% accuracy rate, the medical diagnostics company claimed.
With the breakthrough status, RNT Health Insights now has access to an accelerated review process for acquiring the required marketing permits.
The latest advancement is expected to fast-track the introduction of the cancer detection tool to the market, supporting both patients and healthcare providers.
FDA awards breakthrough device designation to medical devices demonstrating substantial clinical evidence of new advancements in diagnosing or treating life-threatening or irreversibly debilitating diseases or conditions.
The programme especially focuses on the absence of approved alternatives, and when their availability is deemed crucial for patient welfare.
It also aims to ensure timely access to medical devices by accelerating their development, evaluation, and regulatory approval processes.
Additional benefits include expedited device progression, prioritised regulatory submissions, and potentially faster reimbursement after clearance.
