Biomoneta Research, a Bengaluru health tech startup, received US FDA Class II clearance for its medical air-cleaning device, Avata Rx. The update came from several verified reports today. This makes Biomoneta the first Indian company to reach this milestone in the medical air cleaner category.
Avata Rx was designed for hospitals, clinics, and all types of healthcare facilities. The device utilizes the company’s patented ZeBox technology that captures positively charged airborne particles, and traps them on a specific surface. The device targets bacteria, viruses, and fungal spores. It helps improve indoor air quality in rooms where patients and staff need safe airflow.
The clearance comes under the FDA 510(k) Class II category. This category covers devices that must meet strong safety and performance rules before entering medical markets. With this clearance, Biomoneta can now offer Avata Rx for clinical use in the United States.
Biomoneta worked on this device for many years. The team studied airflow, indoor infection risks, and the movement of microbes in closed medical rooms. The researchers performed a series of laboratory-controlled studies to assess the efficiency of the device in removing airborne pathogens. These studies measured both pathogen reductions and improvements in air quality.
The device can support infection control in ICUs, wards, operating rooms, and waiting areas. Many hospitals face limits with older air circulation systems. A device like Avata Rx can help improve indoor air quality without major renovations or modifications to existing buildings.
Additionally, the earlier versions of Biomoneta’s systems were already deployed in several Indian hospitals. These units were used in high risk zones such as intensive care areas and treatment rooms. The company said the new Avata Rx model builds on that work and supports infection control plans that follow international clinical standards.
Following this milestone, Biomona Research reportedly intends to expand its production capacity, as well as develop new business opportunities to provide proven air cleaning solutions to additional healthcare providers who require safe indoor air.
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