Dublin, Ohio-based Monitored Therapeutics, Inc. (MTI) has received FDA 510(k) clearance for its connected spirometer, GoSpiro. The device, which calculates diagnostic-quality air capacity measurement, was designed specifically for use in a non-clinical setting. As calculations are performed inside the device, GoSpiro can work with any smartphone, tablet or computer without the need for separate FDA submissions.
GoSpiro has been clinically-validated to measure lung function quality in the patient’s home with accuracy levels as robust as hospital and laboratory systems. The device transmits data via Bluetooth to any mobile device of the user’s choosing while simultaneously integrating with MTI’s telehealth communication hub called MTI GoHome, where patients and healthcare professionals can communicate via secure email and text.
GoHome works with the company’s cloud-based remote monitoring platform MTI CarePortal, which uses Qualcomm 2Net technology to automatically process physiological test and medication data. By generating reports and creating alerts, the portal allows physicians to identify trends and adapt treatment. The platform integrates with a suite of other telemedicine-provided data streams to monitor a range of diseases including asthma, COPD, heart disease, hypertension and diabetes, and GoSpiro is the company’s first FDA-cleared device in respiratory health.
“Monitored Therapeutics, Inc. continues to strengthen its focus on respiratory disease management with the addition of the GoSpiro,” MTI CEO and cofounder Willan Zimlich said in a statement. “The GoSpiro's 510(k) marks a critical milestone towards completing our system to manage patients with pulmonary disease in their homes. This is one more step towards our goal of improving patients' lives and reducing healthcare costs."
Spirometry is a tried and true measure of lung function, but their use outside of clinical settings is not particularly widespread. While MTI purports to be the first company offering such a device for in-home treatment, there are a few others in the digital respiratory health management space with similar products.
In December, Madison, Wisconsin-based Propeller Health teamed up with Medical International Research offer the Italian health technology company’s mobile and clinical spirometers alongside the Propeller digitally-guided respiratory therapy platform. Other digital respiratory health companies like Sparo Labs and Cohero Health currently offer them with their platforms.