FDA Approves RPM Vital Signs Device


The remote patient monitoring platform delivers data directly to the physician and reduces hospitalizations and emergency department trips.


BioIntelliSense today announced that the US Food and Drug Administration (FDA) granted 510(k) clearance for its vital signs remote patient monitoring on-body sensor.

BioSticker is worn on the upper left chest so patients can experience a “stick it on and forget it” type of experience while it measures respiratory rate, heart rate at rest, and skin temperature. The medical device also tracks body position, gait analysis, activity levels, and sleep status, as well as detects falls and symptomatic events.

The platform wirelessly delivers the data via Bluetooth to clinicians from patients in their home and has the potential to lead to early detection of avoidable complications. The data from the BioSticker will help healthcare providers see if a patient is at risk of becoming ill hours, days, or even weeks before they become symptomatic, Richard Zane, MD, chief innovation officer at UCHealth, said in a video. The providers then can treat the patient before they experience a health emergency.

The device could reduce hospitalizations, emergency department visits, and shorten hospital stays, which could create cost efficiencies for health systems and patients alike, Zane added in a statement.

BioSticker is the first FDA-cleared single-use device for up to 30 days of continuous vital signs monitoring, according to BioIntelliSphere representatives.

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