Monitored Therapeutics Inc (MTI), has received FDA 510(k) clearance for its GoSpiro Home Spirometer. This is the first spirometer that was specifically developed as a home-use wireless connected spirometer that works with a wide range of smartphones, tablets or PCs, according to MTI.
Michael Taylor, Chief Development Officer, pointed out that “The GoSpiro is the only spirometer currently on the market that has met the latest and more stringent ISO and FDA device requirements for home use.”
The GoSpiro collects diagnostic quality forced spirometry (FVC) and slow spirometry (SVC) with the same accuracy as hospital laboratory systems and provides immediate feedback to patients on the quality of their test performance.
The GoSpiro seamlessly integrates with MTI’s GoHome Patient Health Monitor, which collects and transmits data from patients and delivers physician’s instructions to them, and joins a suite of remote patient monitoring peripherals already integrated to monitor diseases such as Asthma, COPD, heart disease, hypertension and diabetes.
Monitored Therapeutics, Inc. continues to strengthen its focus on respiratory disease management with the addition of the GoSpiro. “The GoSpiro’s 510(k) marks a critical milestone towards completing our system to manage patients with pulmonary disease in their homes,” said Monitored Therapeutics, Inc. Co-founder and CEO William Zimlich. “This is one more step towards our goal of improving patients’ lives and reducing healthcare costs.”