Pulmonary telehealth gets hot: FDA clears MTI’s Bluetooth spirometer for home use

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/05/GoSpiro.jpg” thumb_width=”150″ /]Monitored Therapeutics, Inc. (MTI) of Dublin, Ohio received FDA 510(k) clearance for a new home spirometer (left) specifically designed to connect via Bluetooth to smartphones, tablets, and PCs. According to Michael Taylor, MTI’s Chief Development Officer, “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.”

Bill Zimlich, MTI’s CEO, told this Editor more about their market and the reasons for its development. “The GoSpiro is the first to be developed specifically for the home, and also the first to pass the home use FDA requirements. “Slow spirometry” is an added differentiating feature for highly impaired patients with idiopathic pulmonary fibrosis (IPF), amyotrophic lateral sclerosis (ALS), cystic fibrosis and other conditions who would have difficulty with the fast exhalation needed for the FEV test.”

Spirometers collect information on the patient’s inhaling and exhaling air in amount (volume) and speed (flow). The GoSpiro measures forced vital capacity (FVC) and slow vital capacity spirometry (SVC) which are the two main tests used to measure lung function in patients. It connects to MTI’s proprietary platform, CarePortal, based on Qualcomm 2Net, and their GoHome Patient Health Monitor. Specifications are listed here but it appears that MTI will not be selling direct to consumer.

Currently, spirometers are infrequently used in the home, which has been to the detriment of patients with pulmonary diseases such as asthma and COPD, plus associated conditions such as heart disease. Existing units have been expensive (from hundreds to thousands of dollars, excepting some new entrants), bulky, and require manual or cabled input to telehealth platforms. While cost is not disclosed, the MTI GoSpiro appears to be the first FDA-cleared home use device to fully change this picture, and in size and type can be easily bundled with a telehealth kit. Press release. Mobihealthnews.

Others in the now-hot pulmonary game are not far behind. (more…)

Qualcomm (Second) Life: a conversation with Jim Mault

One of the surprises for this Editor, and for others attending the mHealth Summit, was to see the sizable presence of Qualcomm Life on both the exposition floor and during the sessions. From a near-nil presence at ATA 2014 and gone dark on news, the floodlights snapped on last week with new partners and a new emphasis: coordination of chronic and transitional (hospital to home) care management (CCM/TCM).

On the show floor, the spotlight was on the partner companies which mixed the established with (mostly) the early and mid-stage. Readers will recognize names such as AliveCor, Telcare, OMRON, Nonin and Airstrip; not so well known are Vaica, Orion Health, Monitored Therapeutics, IMPak Health, Vital Connect, Care Connectors, toSense (CoVa), Dexcom, InteliChart, TruClinic, ForaCare, VOXX, vitaphone (outside of Europe), Propeller Health and Noom Health (a NYeC Digital Health Accelerator 2014 graduate). The partners occupy different parts of the management continuum, integrating communications, record sharing, population health management, sensor-based monitoring, traditional and non-traditional vital signs monitoring, medication management, behavioral change methodologies and PHRs. The 2net Hub is still present for data transmission, sharing and storage, but more prominent is Qualcomm Life’s HealthyCircles platform which provides the clinical management ‘glue’: secure communications, record sharing and care team coordination. HealthyCircles was purchased in mid-2013. Founder James Mault, MD, FACS joined Qualcomm Life as VP/Chief Medical Officer.

We had some post-mHealth Summit reflection time by telephone this Wednesday while Dr Mault was in Boston. (more…)