FDA Approves Sotera Wireless Technology for Monitoring Vital Signs

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.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.