August 18, 2020
Sweden-based digital therapeutics respiratory company, NuvoAir, has been certified as a Class Im medical device.
The NuvoAir Home platform includes Air Next, a certified bluetooth spirometer, a connected patient app and a healthcare portal.
WHY IT MATTERS
Patients can use the platform to self-monitor their respiratory health and share clinically relevant data with their care teams, who can view...
January 9, 2020
Respiratory monitor maker NuvoAir (formerly Pond Healthcare Innovation) has picked up its first FDA 510(k) for Air Next, a portable and connected home-use spirometer device.
According to the FDA’s premarket notification database, the Stockholm, Sweden-based company submitted its application in November 2018, and received the decision last Thursday.
The Air Next is designed for patients with...
April 18, 2017
Dublin, Ohio-based Monitored Therapeutics, Inc. (MTI) has received FDA 510(k) clearance for its connected spirometer, GoSpiro. The device, which calculates diagnostic-quality air capacity measurement, was designed specifically for use in a non-clinical setting. As calculations are performed inside the device, GoSpiro can work with any smartphone, tablet or computer without the need for separate...
December 1, 2016
Madison, Wisconsin-based Propeller Health, which offers a digitally-guided respiratory therapy platform, has teamed up with Medical International Research (MIR) to offer several of the Italian health technology company’s mobile and clinical spirometers alongside the Propeller system.
The addition of sprirometers will give Propeller a more complete vision of the people using their platform, which...
November 21, 2016
St. Louis-based Sparo Labs is now selling Wing, its FDA-cleared, over-the-counter smartphone sensor to manage asthma and other respiratory conditions. The device was cleared in June and is available directly to consumers, although the company has also indicated they are eyeing pharma and providers as potential distribution channels as well.
Wing is a pocket-sized spirometer with a cloud-connected...
June 30, 2016
Wing, an app-connected spirometer from St. Louis, Missouri-based Sparo Labs, is ready to take flight. The FDA recently cleared the device with an over-the-counter clearance, meaning the company can market it directly to consumers, but Sparo sees provider and pharma channels as important ones too.
With Wing, Sparo aims to help people manage asthma and other respiratory conditions, such as COPD...
May 4, 2016
A research team from the University of Washington has adapted a smartphone-based spirometry test to work with any kind of phone, including feature phones and landline phones, and to deliver clinically accurate results.
Back in 2012, the University developed a smartphone app, SpiroSmart, that would use the measure lung function using the phone's microphone. But in attempting to put the device to...
June 2, 2015
New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer. The Bluetooth-connected device measures critical lung function with comparable accuracy to clinical-grade spirometers, and sends the data to a smartphone or tablet.
Cohero Health has already been using the spirometer as part of its medication adherence tracking platform in a pilot at Mount...
August 5, 2014
In the latest update to the iOS 8 beta, Apple added a number of health-related features, according to various reports. Most notably, the company added a data tracking capability for spirometry, which is data about how obstructed the lungs are collected by people with conditions like asthma or COPD.
Apple announced its Health app and HealthKit developer package at its WWDC event in June. The app...
February 15, 2012
Annapolis, Maryland-based asthma monitoring technology company iSonea has inked a deal with Qualcomm Life, a subsidiary of Qualcomm, to combine iSonea's proprietary Acoustic Respiratory Monitoring (ARM) devices and forthcoming mobile health asthma management offerings with Qualcomm's recently launched 2net platform.
The deal will enable users of iSonea's asthma monitoring...