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…)

A weekend potpourri of health tech news: mergers, cyber-ransom, Obama as VC?

As we approach what we in these less-than-United States think of as the quarter-mile of the summer (our Independence Day holiday), and while vacations and picnics are top of mind, there’s a lot of news from all over which this Editor will touch on, gently (well, maybe not so gently). Grab that hot dog and soda, and read on….

Split decision probable for US insurer mergers. The Aetna-Humana and Anthem-Cigna mergers will reduce the Big 5 to the Big 3, leading to much controversy on both the Federal and state levels. While state department of insurance opposition cannot scupper the deals, smaller states such as Missouri and the recent split decision from California on Aetna-Humana (the insurance commissioner said no, the managed care department said OK) plus the no on the smaller Anthem-Cigna merger are influential. There’s an already reluctant Department of Justice anti-trust division and a US Senate antitrust subcommittee heavily influenced by a liberal think tank’s (Center for American Progress) report back in March. Divestment may not solve all their problems. Doctors don’t like it. Anthem-Cigna have also had public disagreements concerning their merged future management and governance, but the betting line indicates they will be the sacrificial lamb anyway. Healthcare Dive today,  Healthcare Dive, CT Mirror, WSJ (may be paywalled) Editor’s prediction: an even tougher reimbursement road for most of RPM and other health tech as four companies will be in Musical Chairs-ville for years.

‘thedarkoverlord’ allegedly holding 9.3 million insurance records for cyber-ransom. 750 bitcoins, or about $485,000 is the reputed price in the DeepDotWeb report. Allegedly the names, DOBs and SSNs were lifted from a major insurance company in plain text. This appears to be in addition to 655,000 patient records from healthcare organizations in Georgia and the Midwest for sale for 151 – 607 bitcoins or $100,000 – $395,000. The hacker promises ‘we’re just getting started’ and recommends that these organizations ‘take the offer’. Leave the gun, take the cannoli.  HealthcareITNews  It makes the 4,300 record breach at Massachusetts General via the typical unauthorized access at a third party, once something noteworthy, look like small potatoes in comparison. HealthcareITNews  Further reading on hardening systems by focusing on removing admin rights, whitelisting and endpoint security. HealthcareDataManagement

Should VistA stay or go? It looks like this granddaddy of all EHRs used by the US Veterans Health Administration will be sunsetted around 2018, but even their undersecretary for health and their CIO seem to be ambivalent in last week’s Congressional hearings. According to POLITICO’s Morning eHealth newsletter, “The agency will be sticking with its homegrown software through 2018, at which point the VA will start creating a cloud-based platform that may include VistA elements at its core, an agency spokesman explained.” Supposedly even VA insiders are puzzled as to what that means, and some key Senators are losing patience. VistA covers 365 data centers, 130 separate VistA systems, and 834 custom installations, and is also the core of many foreign government systems and the private Medsphere OpenVista. 6/23 and 6/24

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/01/Overrun-by-Robots1-183×108.jpg” thumb_width=”150″ /]Dr Eric Topol grooves on ‘The Fourth Industrial Revolution’ of robotics and AI. (more…)

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.