FDA approved HealthPatch

FDA approved HealthPatch

Already having received the European CE mark, HealthPatch MD vitals, falls, and posture monitoring patch wins FDA clearance.

May 24, 2014
Manufacturing Group
Industry/Regulations Contract Manufacturing Design/Engineering Devices/Implants/Equipment

San Jose, California – Vital Connect received FDA 510(k) clearance for its HealthPatch MD chest monitor that records one lead ECG, heart rate, heart rate variability, respiratory rate, and skin temperature, but that also has an accelerometer to recognize the posture of the person and detect falls. The system consists of a disposable patch and a reusable sensor that stores all the data and transmits it to another device for viewing using Bluetooth 4.0. The patch goes onto the skin using one of three adhesives, made out of either silicone or a hydrocolloid, depending on the activity level expected during monitoring. The battery life is between 48 and 72 hours and the patch is water resistant. The HealthPatch MD already received the European CE mark of approval.

For a detailed look at the HealthPatch, read the article from TMD’s April issue.

Source: Vital Connect