FDA clears Sotera ViSi mobile patient monitoring system

21 August 2012 (Last Updated August 21st, 2012 18:30)

Sotera Wireless, a medical device company based in San Diego, California, has gained 510(k) FDA clearance for its wireless ViSi mobile patient monitoring system.

Sotera Wireless, a medical device company based in San Diego, California, has gained 510(k) FDA clearance for its wireless ViSi mobile patient monitoring system.

The ViSi mobile system, which is designed for use in ambulatory, non-ICU clinical settings, leverages WiFi (802.11) wireless technology to transmit patients' vital signs, keeping hospital clinicians connected to their patients.

University of Texas, Arlington, undergraduate nursing programmes professor, associate dean and chair Dr Beth Mancini said the way the majority of ambulatory patients are currently monitored in hospitals worldwide is insufficient and puts them at risk.

"Wireless continuous monitoring of key vital signs holds the promise to substantially change this and allow early detection of patient deterioration and enable rapid response by constantly monitoring all vital signs," Mancini said.

ViSi consists of a small device, slightly larger than a sports watch, and non-invasive sensors that give patients freedom to move.

The system captures and wirelessly transmits core vital signs including blood pressure, heart and pulse rate, 3-lead or 5-lead ECG, SpO2, respiration rate and skin temperature.

Sotera CEO Tom Watlington said patient safety is essential if hospitals and healthcare systems are to avoid the additional cost that can result from avoidable adverse events.

"Like a guardian angel, the ViSi Mobile System is on duty 24 hours monitoring vital signs with the aim of helping clinicians detect early signs of deterioration, allowing clinicians to intervene early to avoid unnecessary escalation of care, while also optimizing use of their time," Watlington said.

Upcoming versions of the ViSi mobile system are expected to include sensing technologies, Sotera's patented continuous non-invasive blood pressure and patient posture and activity.