alveoair bags US FDA clearance for lung health solution

alveoair has been adopted by over 400 healthcare facilities across India

alveofit (Roundworks Technologies Private Limited) announced that its groundbreaking product, alveoair spirometer, has earned US FDA clearance for distribution in the US. Specialising in digital therapeutics for respiratory care, the company is committed to delivering affordable and interoperable lung health solutions.


The US FDA approval, coupled with strategic partnerships like the one with AstraZeneca, positions alveofit for broader international expansion, particularly in the US and emerging economies. Dr Anil Kukreja, VP of Medical Affairs and Regulatory at AstraZeneca Pharma India praised the FDA clearance as a milestone, highlighting alveofit’s role in optimised diagnosis and management of lung disorders such as asthma and COPD.

Since achieving CDSCO certification in India in June 2022, alveoair has been adopted by over 400 healthcare facilities across India. Partnerships with organizations like India Sweden Innovation Centre (ISIHC), NASSCOM COE, PATH, Forge Innovation & Ventures, and DST have helped positively impact the lives of thousands of patients.

As alveofit ecosystem is scaled PAN India, “It is good to see the product mature over the last couple of years and gain acceptance among the providers. I congratulate and wish alveofit a global success with recent approval from FDA, making a difference in the lives of people in India and the world over,” commented Sanjeev Malhotra, CEO, NASSCOM COE.

Neeraj Jain, Country Director – India and Director – South Asia at PATH, commended alveofit for their FDA approval, stating that PATH is actively supporting their spirometry project in Maharashtra’s Satara district for early diagnosis of chronic respiratory conditions.

Furthermore, alveofit collaborates with prominent academic institutions such as AIIMS Delhi for clinical research and has allied with Tatvacare to extend digital respiratory care solutions to patients’ homes.

Earlier this year, to cater to the growing US market, alveofit inaugurated its office in New York.


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