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…)

Peak flow in your pocket: Smart Peak Flow meter/app gets Kickstarted (UK)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/12/smartflow-meter.png” thumb_width=”150″ /]A UK-based startup, Smart Respiratory Products, has successfully Kickstarted its smartphone/tablet-based peak flow meter and app with a total pledge to date of £11,322 (just over $14,000). Targeted to asthmatics, the meter plugs into the 3.5 mm audio jack (left). Like a standard peak flow meter, the user blows into the Smart Peak Flow meter, and the measurement is sent to the app, available through the Apple Store and Google Play. The measurement must be taken in a well-lit area, as the ambient light is chopped up by a photo sensor at the bottom as the patient’s forceful breath passes through a fan. The flashing signal goes into the microphone as a sound file.

The app measures the force of breath and charts it. It also engages the user through challenges, “personal bests” and winning streaks. There are also virtual badges awarded and snappy ‘earned quotes’. Those who take the ’90 Day Challenge’ of daily use receive an inhaler monitor, a cap that transmits to the phone when the inhaler is used.

Smart does not mention other respiratory uses for the peak flow meter, such as COPD.

According to MedCityNews, the company plans to complete its 510(k) and CE Mark applications by mid-2017. They will ship IFU prototypes to its Kickstarter supporters in February. The pricing on Kickstarter for the device is £10 with deluxe versions starting at £16. MedCityNews also noted that Sparo Labs’ Wing, which we profiled in November 2015, gained its FDA clearance in June but is at a $129 price. Founder Thomas Antalffy of Smart:  “I have spoken to pharmaceutical companies, and the dream for me would be to include Smart Peak Flow or the smart inhaler with every box of inhalers people buy.” At his prices, it might be possible.

Wing: a device that warns prior to asthma attacks

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/11/wing-device-964×644.jpg” thumb_width=”150″ /]A St Louis, Missouri startup, Sparo Labs, has developed what they term an ‘early warning device’ for asthma attacks. The Wing pocket-size sensor which connects to a smartphone app (iPhone 5 and later, Android soon) measure both peak flow (how fast you can blow out air) and FEV1 (how much air you blow out in 1 second). The app measures it against personal levels (80-100 percent of best is fine, 50-80 percent is caution and below 50 percent is red zone) so that a person (or caregiver) receives an accurate reading of their breathing level; if something is wrong, the person can take their medication and/or seek assistance. For the 10 percent of Americans who have difficulty breathing, not just from asthma but living with COPD, cystic and pulmonary fibrosis, bronchitis and other respiratory conditions, the Wing’s compact design and under-$200 price point won’t leave them breathless. Wing is financing/testing on Indiegogo with a 20 Nov goal of $50,000 ($32,000 to date), awaiting 510(k) FDA clearance with an in-market date of August 2016. PSFK blog, Gizmag,Hat tip to Toni Bunting, our former N. Ireland Editor.