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

click to enlargeMonitored 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.

  • Propeller Health, which has been innovative in developing a sensor for asthma inhalers and a management/education platform primarily targeted to asthma patients, in December inked a deal with Italy’s Medical International Research (MIR) to offer their spirometers in the US (Mobihealthnews).
  • Cohero Health’s mSpirometer connects via Bluetooth to a smartphone and their proprietary platform. It was FDA cleared in June 2015, but according to their website, it is still in clinical study. Cohero last month named a new CEO after oversubscribing a $9 million Series A.
  • Sparo Labs’ Wing was cleared in June 2016. The Wing connects to their platform via a 3.5 mm cabled plug to a smartphone audio jack. It’s now available for $79 via their website.
  • In the UK, Smart Respiratory Products Kickstarted their peak flow meter targeted to asthmatics [TTA 16 Dec]; again, this connects to and sits on top of the smartphone audio jack. Their plans were to complete its 510(k) and CE Mark applications by mid-2017, and to ship IFU prototypes to its Kickstarter supporters in February. The pricing on their pre-order site ranges from £10 to £22, far less than Wing’s, but not available in the US.
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