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The new clearance will allow the device to be worn for the full length of the average hospital stay.
A wearable biosensor made by VitalConnect has received FDA clearance that will allow it to be worn for the duration of the average hospital stay.
The VitalPatch, which was first approved by the FDA in late 2015 and launched in 2016, is a disposable peel-and-stick health patch that monitors 8 vital health signs within a hospital setting. The device can report heart rate, heart rate variability, respiratory rate, and skin temperature while detecting activity, posture, and falls. The information is reported to clinicians in real time through a mobile platform.
The patch’s previous 510(k) indication allowed it to be worn for up to a 96-hour (4 day) hospital stay. The newly-announced clearance extends that to 120 hours (5 days). According to the US Department of Health and Human Services, the national average for an admitted hospital stay is 4.5 days.
VitalConnect’s website, however, still lists the device’s battery life at 96 hours. Neither the company’s official statement nor the new 510(k) clearance clarify battery life, with the FDA report listing “Battery Performance Testing” as “N/A,” citing “internal performance testing.” Because the new clearance involved no changes to the technology itself, firmware validation was the only regulatory test considered.
The company says that the extended clearance makes their device “ideally suited for hospital patient monitoring.” The biosensor can also be used outside of hospitals to remotely monitor vital signs post-discharge or in clinical trial settings.
The roughly 4.5-inch-long flexible patch is meant to be unobtrusive, rising less than a half-inch above the skin. It is meant to be worn on the left side of a patient’s chest, near the heart. VitalConnect calls their device “the industry's smallest and lightest wearable biosensor.”
The company has been making significant financial moves lately. It secured a $20 million loan from Oxford Finance at the end of November, according to Crunchbase. Less than a month earlier, it closed a Series C funding round worth $38 million.
"We envision a hospital of the future where inpatient and outpatient care needs integrate more seamlessly to enable a patient-centric model of care that is truly preventative and real-time,” VitalConnect founder and CEO Nersi Nazari said after the new funding, which he indicated would go towards further product development and rollout.