FDA clears first 'smart' spirometer, enabling continuous tracking of lung function via tablet

CoheroHealth announced FDA clearance of the first mobile spirometer for use in the home, enabling continued tracking of lung function between visits to the doctor via smartphone or tablet computer.

Mobile Spirometer--Courtesy of CoheroHealth

The device adds to Cohero's asthma and COPD management platform, consisting of smart inhalers with Bluetooth sensors that track medication usage. Spirometers measure the speed and volume of air inhaled and exhaled by the lungs when patients breathe into the device's mouthpiece. Cohero's device will track lung health metrics like forced vital capacity and forced expiratory volume.

Data about a patient's lung function obtained from the mobile spirometer be will transmitted via Bluetooth to Cohero's pediatric and adult mobile medical apps, AsthmaHero and BreatheSmart. They already display patients' usage of rescue and maintenance inhalers for asthma/COPD, and deliver reminders to use the drug delivery devices in a compliance with doctors' orders.

The goal of connected devices like Cohero's new mobile spirometer is the continuous generation of data, which can be used to make real-time decisions and improve the healthcare system, by for example, creating new ways to encourage patient adherence to dosing instructions. In addition, Cohero says the data can integrated into the clinical workflow so that doctors can use the information to determine which patients are not responding the medication and may need a change of therapy.

"We are enhancing respiratory care by recording critical measurements over time outside of a physician's office," said Cohero Health co-founder and CEO, Melissa Manice, in a statement. "This longitudinal view of changes in lung function over time, in parallel with medication adherence tracking, equips physicians to partner with their patient to make more informed treatment decisions together. We're really excited to be leading a new era of collaborative data driven clinical decisions."

Last year, Cohero said it will test its platform on 50 patients at New York City's Mount Sinai Medical Center. The plan included giving patients rewards, such as gift cards, for compliance. Cohero says its pilots show that the platform increases medication adherence and reduces hospitalizations. The company plans additional pilots, with a full launch scheduled for later this year, according to the release trumpeting the FDA clearance.

Cohero says that prior to the clearance, lung function measurements could only be taken outside of a healthcare facility using a peak flow meter, which it claims is less accurate, requires manual logging of results, and tracks one metric, the maximum speed of exhalation.

Meanwhile, competitor Propeller Health is designing Bluetooth sensors specifically for Boehringer Ingelheim's Respimat inhalers, in an attempt to help the pharma bigwig differentiate its meds.

Large-scale tracking of inhaler usage would enable interesting Big Data research with broader applications that extend beyond a single patient. CVS Health ($CVS) CEO Larry Merlo has said that medication nonadherence is costing the healthcare system about $300 billion per year in unnecessary costs.

- read the release

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