The US Food and Drug Administration (FDA) has granted 510(k) clearance to the alveoair digital spirometer, according to a press release by the manufacturer, alveofit (Roundworks Technologies Private Ltd; Pune, India).
According to the company’s website, the portable PFT device is designed for patients with asthma, COPD, cystic fibrosis or interstitial lung disease.
This FDA clearance, coupled with strategic partnerships including with AstraZeneca, positions alveofit for broader international expansion, particularly in the United States and emerging economies, according to a company news release.
Anil Kukreja, MD, vice president of medical affairs and regulatory at AstraZeneca Pharma India, says in a release that the FDA clearance underscores 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. Partnerships have been forged with organizations like India Sweden Innovation Centre, NASSCOM COE, PATH, Forge Innovation and Ventures, and DST.
“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,” says Sanjeev Malhotra, CEO of NASSCOM COE, in a release.
Alveofit also collaborates with 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 US market, alveofit inaugurated its office in New York.
Photo caption: Alveofit ecosystem
Photo credit: Alveofit / PR Newswire