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Alveofit's Alveoair Spirometer Receives US FDA Clearance for Expansion in the United States

Written by : Jayati Dubey

September 7, 2023

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With the recent U.S. FDA approval and strategic partnerships, such as the one with AstraZeneca, Alveofit is prepared for global expansion, mainly targeting the U.S. market and emerging economies.

Pune-based respiratory care platform Alveofit received U.S. FDA clearance for the distribution of its the Alveoair Spirometer, in the United States. Post receiving the FDA approval, Alveofit looks to expand its global presence in the US market.

This clearance, in conjunction with strategic partnerships, including one with pharmaceutical giant AstraZeneca, has positioned Alveofit for broader international expansion, with a particular focus on the US market and emerging economies.

Dr Anil Kukreja, VP of Medical Affairs and Regulatory at AstraZeneca Pharma India, noted Alveofit's key role in optimised diagnosis and management of lung disorders such as asthma and COPD, highlighting the potential global impact of their product.

Alveofit's journey began with the achievement of CDSCO certification in India in June 2022. Since then, their Alveoair Spirometer has been accessed by more than 400 healthcare facilities across the country.

Alveofit has had collaborative efforts with esteemed organisations including the India Sweden Innovation Centre (ISIHC), NASSCOM COE, PATH, Forge Innovation & Ventures, and DST.

Alveofit's advanced respiratory care also extends to collaborations with prominent academic institutions such as AIIMS Delhi for clinical research. Additionally, an alliance with Tatvacare aims to bring digital respiratory care solutions directly to patients' homes, further enhancing accessibility and convenience.

Earlier this year, Alveofit made strategic moves to cater to the growing US market by inaugurating its office in New York.

The Alveoair Spirometer, as India's first US FDA-cleared portable digital spirometer, represents a significant leap in respiratory care technology.

Alveofit's ecosystem offers real-time insights to healthcare professionals. These insights empower timely interventions in respiratory care, leading to advanced analytics that can provide predictive insights through AI models.

Earlier this year, in another development in respiratory care, innovators from the IIT-Mandi startup, Dectrocel Healthcare, created an AI-powered medical imaging solution that could transform the early detection of respiratory abnormalities, hepatobiliary diseases, and genetic disorders in children.

Dectrocel Healthcare's pioneering platform allows for the speedy analysis of both digital and analogue chest X-ray images as well as images of children. In just a matter of minutes, their algorithm can accurately diagnose respiratory abnormalities, including life-threatening conditions such as tuberculosis and Chronic Obstructive Pulmonary Disease (COPD).

These tools enable clinicians to prioritise cases and deliver quality care, ultimately contributing to improved patient outcomes.


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