Bengaluru startup first Indian firm to get US-FDA Class II nod for medical air cleaners
BENGALURU: Biomoneta has become the first Indian healthtech company to receive US-FDA 510(k) Class II clearance for a medical air-cleaning device, marking a key milestone in its efforts to expand into the US healthcare market.
“The clearance covers the Biomoneta Avata Rx Medical Recirculating Air Cleaner, which is built on the company’s patented ZeBox technology. Unlike conventional systems that rely on HEPA filters, UV radiation or ozone-based processes, ZeBox uses nanomaterials and a non-ionising electric field to pull naturally charged microbes out of the air,” the firm said.
These microbes are then trapped on microbicidal surfaces and eliminated. Independent lab tests have shown more than 99.9% efficacy against pathogens, including SARS-CoV-2 , H1N1 and Mycobacterium tuberculosis.
Biomoneta co-founder and CEO Arindam Ghatak said the FDA decision capped an eleven-year research effort aimed at preventing hospital-acquired infections . He said the approval would allow the company to deploy its systems in US hospitals and critical-care units.
The recognition follows another recent milestone for the startup. Biomoneta was named one of the nine winners of the C-CAMP AMR Challenge 2024-25, supported by the Global AMR Innovation Fund of the UK govt.
Under this programme, the company is working on “qAMI”, an AI and machine learning-based platform that measures airborne pathogens in real time to support infection-control efforts. C-CAMP director and CEO Taslimarif Saiyed said the FDA clearance would speed up global adoption of the technology and reflected the growing strength of India’s biotech and medtech sector.
The company said the approval comes at a time when India continues to face high levels of air pollution and a significant burden of airborne diseases , particularly in hospitals and crowded indoor spaces. With ISO 13485:2016 accreditation in place, Biomoneta plans to scale manufacturing and distribution of Avata Rx to meet rising demand for clinical-grade air purification.
Founded in 2014, Biomoneta has received support from BIRAC, the Karnataka govt and C-CAMP. It raised seed funding in 2020 through the C-CAMP-BNV Innovation Hub, along with investments from Indian and international investors.
“The clearance covers the Biomoneta Avata Rx Medical Recirculating Air Cleaner, which is built on the company’s patented ZeBox technology. Unlike conventional systems that rely on HEPA filters, UV radiation or ozone-based processes, ZeBox uses nanomaterials and a non-ionising electric field to pull naturally charged microbes out of the air,” the firm said.
These microbes are then trapped on microbicidal surfaces and eliminated. Independent lab tests have shown more than 99.9% efficacy against pathogens, including SARS-CoV-2 , H1N1 and Mycobacterium tuberculosis.
Biomoneta co-founder and CEO Arindam Ghatak said the FDA decision capped an eleven-year research effort aimed at preventing hospital-acquired infections . He said the approval would allow the company to deploy its systems in US hospitals and critical-care units.
The recognition follows another recent milestone for the startup. Biomoneta was named one of the nine winners of the C-CAMP AMR Challenge 2024-25, supported by the Global AMR Innovation Fund of the UK govt.
Under this programme, the company is working on “qAMI”, an AI and machine learning-based platform that measures airborne pathogens in real time to support infection-control efforts. C-CAMP director and CEO Taslimarif Saiyed said the FDA clearance would speed up global adoption of the technology and reflected the growing strength of India’s biotech and medtech sector.
The company said the approval comes at a time when India continues to face high levels of air pollution and a significant burden of airborne diseases , particularly in hospitals and crowded indoor spaces. With ISO 13485:2016 accreditation in place, Biomoneta plans to scale manufacturing and distribution of Avata Rx to meet rising demand for clinical-grade air purification.
Founded in 2014, Biomoneta has received support from BIRAC, the Karnataka govt and C-CAMP. It raised seed funding in 2020 through the C-CAMP-BNV Innovation Hub, along with investments from Indian and international investors.
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