3 FDA-Approved Mobile Health Sensor Devices You Should Know

Mobile health sensors are transforming how we track our well-being, but a subset cleared by the FDA has the potential to change forever how diseases are managed by patients and providers.

The mobile health sensor market is witnessing rapid growth with one 2013 report forecasting that it will be worth $5.6 billion by the year 2017.

Nestled in the health, wellness and self-tracking segment, most of these will likely lie outside the purview of the Food and Drug Administration. But there are mobile health sensor companies that are trying to improve people’s health and well-being by providing very precise clinical information about their bodies and helping them and their physicians manage their conditions, chronic or otherwise. 

Here are three FDA-cleared health sensor devices, starting with the one that received the regulatory nod most recently

Propeller Health’s Sensor and Software Platform

The Propeller Health System 

Last week Propeller Health, formerly known as Asthmapolis, announced that it won FDA clearance for a new sensor and software platform that aims to help physicians understand and manage asthma, chronic obstructive pulmonary disorder and other respiratory illnesses to prevent emergency hospitalizations. The previous generation won clearance in July, last year.

A sensor attached to a rescue inhaler carried by asthma and COPD patients is able to track when and where the rescue inhaler is used. Patients can share the data with their physicians who can remotely monitor them and identify who has worsening COPD symptoms, who is not adhering to the medication regimen and who has uncontrolled asthma. That information can be used to send reminders to patients to take their medication and other forms of alerts and notifications.

The new clearance also allows the Propeller Health system to be able to predict worsening symptoms in asthma and COPD patients.

The newly-approved sensor is 30% smaller and features a new collar that removes the need for adapter caps. It also eliminates the need for charging and has a battery life of more than 18 months.

“Our goal is to minimize or eliminate exacerbations – that drives everything we do. Key to that, particularly as we move deeper into COPD, is optimizing both the patient and provider experience on Propeller,” said David Van Sickle, CEO of Propeller Health, in the news release announcing the new FDA clearance.

Proteus Digital Health’s Ingestible Sensor

How the Ingestible Sensor Works

A fair amount of cyberspace has been expended upon Proteus Digital Health, precisely because it aims to create a whole new category of digital medicine that can solve one of the intractable problems of the pharmaceutical industry - patients not taking or simply forgetting to take their medication.

Like Propeller Health, Proteus also intends to improve disease self-management. In July 2012, it won FDA approval for a pill containing an ingestible sensor that communicates information to a wearable patch about when the patient took a medication, the physiological response to the drug as well as activity and rest patterns of the patient. The patch in turn relays that data to a patient’s smartphone. The data can be shared with various people in the patient’s network including family and healthcare providers

Today, patients are required to take the Proteus pill at the same time that they take their regular doctor-prescribed medication, but the company is working with pharmaceutical companies such that future medications will contain the ingestible sensor that it has developed. Proteus has partnerships with Novartis and Otsuka Pharmaceuticals.

But the company’s investors include such pharma companies as well as device makers like Medtronic, technology companies like Oracle and ON Semiconductor and integrated health systems like Kaiser Permanente.

AgaMatrix/Sanofi's iBGStar Blood Glucose Meter

AgaMatrix and Sanofi’s iBGStar iPhone-connected blood glucose sensor
AgaMatrix, a maker of glucose meters for diabetics,  and  drugmaker Sanofi teamed up to create and commercialize the first iPhone and iPod-connected blood-glucose meter and won the blessing of the FDA in December, 2011.

Called iBGStar, the sensor-powered blood glucose meter can be used separately or with Apple mobile devices and the iBG Diabetes Manager App. The device can track blood sugar readings, carb intake, and insulin doses. Patients can also tag results to note whether the reading was taken before a meal or after exercise.
Like Propeller Health and Proteus Digital’s sensor-powered devices and related software, iBGStar can communicate the data to the patient’s healthcare team, if the patient decides to do so.




All the above devices are ways to remotely monitor patients by enabling data share. The subject of remote monitoring's journey in healthcare will be addressed at a keynote discussion at the MD&M East Conference & Exposition June 12 by experts from Covidien and Soteira Wireless. 

-- By Arundhati Parmar, Senior Editor, MD+DI


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