Monitored Therapeutics’ First Wireless Spirometer for Home Use Cleared by FDA
Monitored Therapeutics received a 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its GoSpiro Home Spirometer, the first specifically developed as a home-use device for patients with chronic obstructive pulmonary disease (COPD).
“The GoSpiro’s 510(k) marks a critical milestone towards completing our system to manage patients with pulmonary disease in their homes,” William Zimlich, co-founder and CEO of Monitored Therapeutics, said in a press release. “This is one more step towards our goal of improving patients’ lives and reducing healthcare costs.”
GoSpiro can wirelessly connect with smartphones, tablets or personal computers, and is designed to collect diagnostic-quality forced spirometry (FVC) and slow spirometry (SVC) with the same accuracy as hospital laboratory systems, providing immediate feedback to patients.
The device can integrate with Monitored Therapeutics’ GoHome Patient Health Monitor, which collects and transmits data from patients, in turn delivering messages and instructions from physicians.
GoSpiro joins then a suite of remote patient monitoring peripherals already integrated to monitor diseases like asthma, COPD and heart disease, as well as diabetes or hypertension.
GoSpiro is the only spirometer in the market that has met the latest and more stringent requirements both from the FDA and from the International Organization for Standardization (ISO). The device not only provides diagnostic test results, but it also makes them acceptable for clinical trials conducted at home.
According to the company’s website, some of GoSpiro’s additional characteristics include:
- Real-time flow and volume streaming data for on-screen visualization;
- Full flow-volume loops with both inspiratory and expiratory data analysis;
- Automated slow vital capacity and subdivisions protocol;
- Volume-based measurement provides for long-term calibration stability;
- Built-in quality control with measured and calculated error indices;
- Bluetooth-enabled wireless communication;
- Interfaces to computers, tablets and smartphones and any other compatible collection hub.
Furthermore, the GoHome Platform offers users an avatar called “Lisa” that provides real-time patient coaching.
Monitored Therapeutics is a company focused on creating and developing remote patient management technology. Its technologic platform increases patient engagement, adherence to treatment and the patient’s quality of life, while decreasing the overall healthcare costs by keeping patients in their homes instead of in the hospital.