Prime Highlights:
- Biomoneta is the first Indian health-tech firmto receive US FDA clearance for a medical air-cleaning device.
- The Avata Rx systemcan eliminate airborne infections, including viruses and bacteria, in high-risk indoor spaces.
Key Facts:
- FDA approval allows Biomoneta to introduce Avata Rx in hospitals, clinics, and laboratories in the US.
- The company plans to expand manufacturing and distribution worldwideto meet growing demand for clinically tested air hygiene solutions.
Background:
Bengaluru-based healthtech company Biomoneta has achieved a landmark milestone by receiving clearance from the U.S. Food and Drug Administration (FDA) for its Avata Rx Medical Recirculating Air Cleaner. The approval places Biomoneta in the record books as the first Indian health-tech company to obtain a US FDA 510(k) Class II clearance for a medical air-cleaning device, underscoring India’s rising capabilities in advanced med-tech innovation.
The Avata Rx system operates on Biomoneta’s proprietary ZeBox technology, a unique non-filter air-cleaning platform that uses an electric-field mechanism to capture and neutralise harmful airborne microbes. Independent laboratory studies show that the technology can eliminate more than 99.9999 percent of pathogens, including viruses such as SARS-CoV-2 and H1N1, as well as resilient bacteria like Mycobacterium tuberculosis, which are often challenging to eradicate using conventional systems.
With this approval, Biomoneta can now introduce Avata Rx in hospitals, clinics, laboratories, and critical-care settings in the United States. The company said the approval supports its global growth plans and recognizes years of research on the ZeBox technology.
After the approval, Biomoneta plans to make more devices and sell them worldwide, as demand grows from healthcare and biotech facilities looking for proven air-cleaning solutions. The company says the system can cut airborne infections in high-risk indoor spaces.
The FDA approval comes as infection prevention is crucial, especially in healthcare settings. Biomoneta’s success is a proud moment for India, showing the country is getting global recognition for innovation.
