Bengaluru: Biomoneta Research Private Limited, a Bengaluru-based health-tech startup, has become the first Indian company to receive US FDA 510(k) Class II clearance for its Biomoneta® Avata Rx Medical Recirculating Air Cleaner. This clearance allows Biomoneta to enter the US healthcare market with its patented ZeBox technology, marking a major milestone in the company’s decade-long R&D journey.

The Avata Rx uses the ZeBox platform, a unique approach that removes airborne microbes using nanomaterials and a non-ionizing electric field, rather than HEPA filters or UV systems. Tests show it eliminates over 99.9999% of pathogens, including SARS-CoV-2, H1N1, and Mycobacterium tuberculosis.

“This FDA clearance validates everything our team has worked toward over the last eleven years,” said Dr. Arindam Ghatak, Co-founder and CEO of Biomoneta. “We set out to prevent hospital-acquired infections and now can bring ZeBox-powered solutions to US hospitals and critical-care environments, meeting a global need for safer indoor spaces.”

Biomoneta was also named one of the nine winners of the C-CAMP AMR Challenge 2024-25, developing AI-enabled qAMI technology to monitor airborne pathogens in real time.

Dr. Taslimarif Saiyed, CEO of C-CAMP, said, “This US FDA clearance is a major achievement and highlights the growing impact of India’s biotech ecosystem. Biomoneta’s innovation delivers real societal value.”

With ISO 13485:2016 certification and plans to scale production, Biomoneta aims to meet rising global demand for clinical-grade air purification, helping hospitals worldwide improve air safety and prevent infections.