FDA Clearance for Aluna Asthma Management Platform
Aluna, the San Francisco Bay Area-based company, today announced that it has received FDA clearance. FDA clearance is for its flagship device and companion smartphone app for consumer sale and use. A team of asthmatics and healthcare providers designed the Aluna platform from the ground up.
Aluna helps patients, particularly pediatric patients, better manage their asthma by recording and tracking lung function scores. Better tracking of lung function can help prevent asthma attacks and flare-ups, resulting in controlled and managed asthma.
“This FDA clearance is a watershed moment for our company and for asthmatics everywhere. As asthmatics ourselves, my co-founders and I are personally and acutely aware of the daily struggle of living with asthma. Children often struggle to communicate the symptoms that they are experiencing or recognize certain triggers that should alter their behavior. Now, with our device, kids have the ability to instantly measure their lung health, track and monitor ongoing symptoms. They can also see their data over time – ultimately helping them better self-manage their asthma. We believe that the Aluna will help asthmatics everywhere better manage their condition, empowering them to live life to its fullest. Use of Aluna will enable more informed and open dialog between patients and their doctors about how to best cope with this chronic disease.”
Aluna is an innovative, mobile respiratory management platform that monitors lung function scores, effectively duplicating the spirometry exams typically performed in a doctor’s office. It consists of a small spirometer that pairs, via Bluetooth, with a companion iPhone app. To use, patients exhale forcefully into the device, just as they would for a physician’s spirometry exam. The paired app displays a patient’s progress and score.
To view Aluna in action, please watch this brief demo video:
When used regularly, Aluna provides a wealth of insight to better manage this chronic disease. It records and outputs real-time data, in PDF format, for both patient and doctor review.
The data provides a more holistic view of the patient’s lung function than is possible with occasional visits to doctors’ offices. This has several key benefits. Using Aluna teaches children to develop autonomy over their asthma action plans. It does this by keeping them, along with their parents and physicians, informed about their lung function. This allows parents to more closely monitor their children’s asthma on a daily basis.
Physicians can adjust asthma action plans as needed with a greater understanding of potential asthma triggers. Most importantly, better management of asthma should result in fewer asthma attacks and flare-ups, and therefore less need for emergency rescue medication, the kind of which is administered in the event of an asthma attack. These rescue medications are linked to a variety of side effects and tolerances can be developed over time, potentially resulting in less effective asthma relief.
“As a pediatric pulmonologist, I directly oversee the care of many asthmatic children,” said Ngoc Ly, MD, MPH, Co-Director of the Cystic Fibrosis Center at the University of California – San Francisco (Dr. Lycontributed to the development of the Aluna platform). “The development and FDA clearance of Aluna will help asthmatics everywhere, especially children, gain a better understanding of and more effectively manage this disease.”
There is a tremendous need for Aluna and for better asthma management. According to the Centers for Disease Control, more than 26 million Americans have asthma. This rate has increased over the past four decades. 47.5 percent of children age 18 and younger with asthma reported one or more asthma attacks in the past year.
The unpredictability of asthma attacks can make it difficult for many children to pursue activities such as sports, music, and much more. CDC research estimates that asthma directly costs the United States economy more than $80 billion each year. This number does not factor in indirect costs, which include lost time and productivity, including lost school days due to asthma.
Better asthma management will result in improved quality of life for asthmatics while also relieving stress on the national economy.
Aluna plans a consumer launch in the Spring of 2020. Though a prescription is not required, Aluna recommends consulting with one’s physician when using the Aluna platform. To learn more, please visit aluna.io.
Physicians that are interested in purchasing the Aluna Asthma Management platform for their practice, should contact Aluna directly at email@example.com.