Wearable biometric diagnostic patch company VitalConnect said it won an extended FDA 510(k) from the FDA for its VitalPatch wearable biosensor, extending the wear duration from four days to five days.
VitalConnect touts the VitalPatch as the smallest and lightest biosensor designed to measure a combination of single-lead ECG, heart rate, heart rate variability, respiratory rate, skin temperature, body posture, fall detection and activity in steps.
The device is designed for single patient use both in and outside the hospital when specific patient monitoring is require, and is fully disposable, the company said.
San Jose, Calif.-based VitalConnect said that the extension pushes the usability beyond the national average 4.5 days hospital stay.
“The extended wear duration for our fully disposable VitalPatch biosensor supports our commitment toward improving patient care and enabling nurses and physicians to have real-time insight into their patients’ vitals and well-being,” founder & CEO Dr. Nersi Nazari said in a press release.
In November, VitalConnect said it closed a $20 million senior secured term loan with Oxford Finance, according to a press release from the finance firm.
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