Medical Devices

Vital Connect’s home monitoring patch gets FDA clearance

Vital Connect’s patch and companion mobile app to track data such as heart rhythms and falls has received 501(k) clearance for home monitoring use by the U.S. Food and Drug Administration, according to a company statement. The milestone reflects a big push for different ways to flag up potential problems before they require readmissions or emergency treatment.

Its Healthpatch MD biosensor was designed to monitor vital signs including heart rate, heart rate variability, respiratory rate, skin temperature, posture including fall detection and severity, and steps. The senor uses Bluetooth 4.0 to connect to a relay or smartphone. The relay transfers information through Wi-Fi to the cloud and conforms to HIPAA and cyber security guidelines, according to the statement.

Only one year ago, Vital Connect’s Healthpatch MD received CE Mark clearance from the European regulatory authority.

Nersi Nazari, the chairman and CEO, and Steve Zadig, the COO, co-founded the company in 2011. The idea is that physicians would prescribe the patch to patients at risk of readmission and as part of a follow-up treatment program. It is designed to be worn 24 hours a day.


Other indications the company is looking to add cover sleep monitoring, including sleep duration, tracking when the user goes to bed and leaves the bed, sleep actigraphy, and sleep quality, according to its website.

Earlier this year, a report by Berg Insight projected that 19 million patients would use a remote monitoring device by 2018. Cardiac rhythm management accounted for the majority of users.

Alerts when patients fall have also historically been of interest for decades going back to personal alarms that can be triggered to receive medical help. But with a way to track the severity of falls over time, it suggests that the monitor can discern between a minor accident and something more serious. With baby boomers getting older and a recognition that it’s better to keep people in their own homes as long as possible, that data could be useful not only to intervene earlier, but also in assessing whether the falls are part of a pattern for a neurological condition.

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