Biomoneta, a Bengaluru-based healthtech firm, has secured clearance from the U.S. Food and Drug Administration (FDA) for its medical-grade air cleaner — the Avata Rx Medical Recirculating Air Cleaner. This makes Biomoneta the first Indian health-tech company to receive a US FDA 510(k) Class II clearance for a medical air-cleaning device.
The Avata Rx system is built on Biomoneta’s proprietary ZeBox technology platform — which uses an innovative non-filter, electric-field method to capture and neutralise airborne microbes. Independent lab tests indicate that the system eliminates over 99.9999 % of pathogens, including viruses such as SARS-CoV-2 and H1N1, as well as highly resilient bacteria such as Mycobacterium tuberculosis.
With FDA approval secured, Biomoneta can now introduce Avata Rx into hospitals, clinics and other critical-care settings in the United States, marking a major milestone not only for the company, but for India’s health-tech ecosystem at large.
The firm plans to ramp up global distribution and production, aiming to meet rising demand for clinically validated air hygiene solutions in healthcare and biotech environments worldwide.
This clearance arrives at a critical time when infection prevention and control — especially in indoor, high-risk settings — remains a priority globally. Biomoneta’s breakthrough underlines how deep-tech innovations from India are gaining international regulatory validation and positioning the country as a competitive player in global med-tech.
