Spirometer with wireless connection receives FDA clearance

21st April 2017

Enaie Azambuja

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Datasheet

Monitored Therapeutics 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. 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."

Monitored Therapeutics Inc. (MTI) is a privately held Delaware corporation managed by a group of industry veterans and clinicians involved in developing and producing innovative remote patient management technology.

MTI extends Access to Care to patients and providers through its technologic platform, increasing Patient Engagement, Drug Adherence and Quality of Life while decreasing overall healthcare cost by keeping patients in their homes and out of the hospital.

The technology also optimises the health care provider's ability to receive reimbursement in today's payer reimbursement structures for remote patient monitoring and non-face-to-face consultation visits. MTI products include GoHome, GoSpiro, and the MTI CarePortal. Monitored Therapeutics, Inc. is based in Dublin, OH with technology development offices in Garden Grove, CA.