FDA Approves Sotera Wireless Technology for Monitoring Vital Signs

Xconomy San Diego — 

It took a little longer than expected, but FDA regulators have cleared the mobile technology that San Diego’s Sotera Wireless has developed for monitoring hospital patients’ vital signs.

Sotera said in April that the FDA had cleared its ViSi mobile monitor, a device that continuously monitors blood pressure, respiration, skin temperature, blood oxygen levels, and heart rate. The device, which resembles an oversized wristwatch, collects data from sensors on the patient’s chest and a thumb—and transmits the data to a hospital workstation.

With today’s approval of Sotera’s WiFi (802.11) wireless technology for transmitting data, Sotera says it is commencing sales of its ViSi Mobile technology to hospitals nationwide.

When we profiled Sotera more than two years ago, CEO Tom Watlington indicated the company expected at that time to launch its device within a year. The company, founded in 2004 as Triage Wireless, has raised about $46 million from investors that include Cerner Capital, Qualcomm Ventures, Sanderling Ventures, Intel Capital, and the West Health Investment Fund.

The new Palomar Medical Center, which opened this week in the San Diego suburb of Escondido, will use the device, according to a report by Padma Nagappan in U-T San Diego.

In a statement today, Sotera says systems for continuously monitoring patient vital signs are typically used only in acute-care areas of hospitals, such as intensive care units. In other areas, which care for two-thirds of hospitalized patients, vital signs are typically taken in spot checks conducted every four to six hours. The company maintains that its continuous, 24-hour monitoring system can help clinicians detect warning signs before they deteriorate into more serious problems.