Intelesens has received FDA 510(k) clearance for its wearable vital signs monitor, called zensor, which is made to enable patient monitoring outside of the hospital.

“This is a significant milestone for Intelesens and zensor,” the company’s Commercial Manager Stephen Henderson said in a statement. “…FDA clearance gives Intelesens and their customers’ confidence in zensor’s quality, robustness and clinical efficacy.”

Zensor is a small device that clips on to an adhesive patch which also contains electrodes. It can be worn for seven days at a time, while collecting data on respiration rate, three-lead ECG, heart rate and motion. The information collected is then sent via WiFi to the cloud from where clinicians can access it on a PC/Mac or a mobile device. Alternatively, users can access this data by connecting the zensor to a PC via a USB cord.

Intelesens is one of the finalists in the $10 million Qualcomm Tricorder X-Prize, which is looking to create a handheld medical scanning device that can diagnose a number of set conditions and evaluate a slate of vital signs.

In April, the Belfast, Northern Ireland-based company and Scanadu announced that they would combine their teams into one to win the prize.

[Via: mobihealthnews]