San Diego-based Sotera Wireless announced this week that the FDA had given its 510(k) clearance for the full version of its WiFi-enabled ViSi Mobile patient monitoring system, a part of which received an FDA clearance this past March. The full system enables care providers to review near real-time transmissions of patients vital signs no matter if their patients are in their beds or walking around the ward.
This clearance enables the company to begin selling and marketing its full system to healthcare facilities in the United States.
Here's how the company describes its continuous vital signs monitor: "The ViSi Mobile System is designed for use in ambulatory, non-ICU clinical settings and consists of a small device, slightly larger than a sports watch, and comfortable non-invasive sensors allowing for freedom of movement. The system accurately captures and wirelessly transmits all core vital signs (Blood Pressure, Heart Rate / Pulse Rate, 3-lead or 5-lead ECG, SpO2, Respiration Rate, Skin Temperature). Future versions of the ViSi Mobile System, currently in final stages of testing, will also incorporate novel sensing technologies, including Sotera's patented continuous non-invasive blood pressure (cNIBP) as well as patient posture/activity."
The March 510(k) clearance was for the company's standalone device not its entire system.
Sotera Wireless argues that the majority of ambulatory patients in hospitals are not very well monitored today and continuous wireless monitoring will increase patient safety and potentially enable the early detection of patient deterioration.
Over the years Sotera has raised about $50 million in funding from various investors, including Singapore-based global fund EDBI, Cerner Capital, Sanderling Ventures, Qualcomm Ventures, Intel Capital and the West Health Investment Fund. The company also already has a commercial partnership with Cerner and it has also collaborated with San Diego-based Palomar Pomerado Health to integrate its vital signs monitoring devices with Palomar’s Medical Information Anytime Anywhere (MIAA) platform, which aims to provide clinicians with access to patient medical records and vital sign information in real time or near-real time. AirStrip Technologies recently acquired exclusive rights to the MIAA platform, which could signal an as yet unannounced partnership between Sotera and that company.
MobiHealthNews has been tracking Sotera for many years: Back in 2009 we noted that Sotera Wireless had changed its name from Triage Wireless as part of an agreement with Inverness Medical Innovations (now a part of Alere), which marketed products under the Triage brand.
More in the company's press release below:
PRESS RELEASE: SAN DIEGO, Aug. 21, 2012 -- Sotera Wireless, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its full ViSi Mobile® System and is commencing sales to hospitals nationwide. The ViSi Mobile System, as approved, uses WiFi (802.11) wireless technology for transmission of patients' vital signs, keeping hospital clinicians connected to their patients, whether patients are in bed or up and moving around. Earlier this year, Sotera announced 510(k) clearance for its first generation ViSi Mobile Monitor, which encompasses the stand-alone device portion of the system that for the first time provides continuous monitoring of all the core vital signs on a patient worn platform.
"The way the majority of ambulatory patients in general care hospital settings around the world are monitored today is inadequate and may put patients at risk," said Beth Mancini Ph.D., R.N., professor, associate dean and chair for undergraduate nursing programs at the University of Texas at Arlington. "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."
Studies conducted worldwide have consistently shown that patients in any hospital setting may suffer preventable adverse events that could result in prolonged hospitalization, injury or death.
Currently, continuous monitoring systems, which can assist in identifying emerging problems, are typically used only in high-acuity areas of hospitals, such as intensive care units (ICU). In lower acuity areas, which host 60 to 70 percent of hospitalized patients, vital signs are typically collected via spot checks that are conducted at four to six hour intervals.
"Patient safety is essential to hospitals and healthcare systems seeking to avoid the additional cost burden that can result from avoidable adverse events," said Tom Watlington, Sotera's chief executive officer. "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."
The ViSi Mobile System is designed for use in ambulatory, non-ICU clinical settings and consists of a small device, slightly larger than a sports watch, and comfortable non-invasive sensors allowing for freedom of movement. The system accurately captures and wirelessly transmits all core vital signs (Blood Pressure, Heart Rate / Pulse Rate, 3-lead or 5-lead ECG, SpO2, Respiration Rate, Skin Temperature). Future versions of the ViSi Mobile System, currently in final stages of testing, will also incorporate novel sensing technologies, including Sotera's patented continuous non-invasive blood pressure (cNIBP) as well as patient posture/activity.
About Sotera Wireless
Sotera Wireless, Inc. is a San Diego, California based medical device company dedicated to the development, marketing and sale of a new generation of comprehensive vital signs monitoring. Sotera's mission is to improve patient safety by empowering clinicians to detect early signs of deterioration in virtually any care setting and enable early intervention and rapid response, all without limiting the patient's freedom of movement. More information on the company can be obtained at www.soterawireless.com or by sending an email to firstname.lastname@example.org.