Alveoair spirometer earns USFDA clearance for distribution in US
Pune: Alveofit (Roundworks Technologies Private Limited) has announced that its groundbreaking product, alveoair spirometer, has earned U.S. FDA clearance for distribution in the United States.
This U.S. FDA approval, coupled with partnerships like the one with AstraZeneca, positions alveofit for broader international expansion, particularly in the U.S. 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 optimized 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.
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 world over," commented Sanjeev Malhotra, CEO, NASSCOM COE.
Neeraj Jain, Country Director – India & 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 formed an alliance with Tatvacare to extend digital respiratory care solutions to patients' homes.
Earlier this year, to cater to the growing U.S. market, alveofit inaugurated its office in New York.
