As we noted in our recently published Mobile Health: State of the Industry Q1 2012 report, late last month the FDA granted Sotera Wireless 510(k) clearance for its wearable vital signs monitoring device, the ViSi Mobile Monitoring system. Sotera submitted the system to the FDA last August and received Class II 510(k) clearance on March 22nd of this year.
According to the company, "the ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals."
Update: The version of the ViSi system that received FDA clearance does not include wireless transmission of data to computers or mobile devices for alerts, secondary viewing, or connectivity with EMR systems. It also does not include the company's patented cuffless non-invasive blood pressure (cNIBP) sensor. Future versions of ViSi will include both, the company noted in a press release published Wednesday.
Here's how the summary document from the FDA describes the system's intended use:
"The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (H-R), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 ), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments."
While the device's initial intended use is for inside healthcare facilities, the device will likely migrate to outpatient settings and eventually the home.
Sotera has already scooped up 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.
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, which markets products under the Triage brand.
More news from the first quarter of 2012 in our Mobile Health State of the Industry Report here.
More on Sotera's FDA clearance in this FDA 510(k) summary document. (PDF)
Update: Read more details in Sotera's press release, below:
PRESS RELEASE: SAN DIEGO – April 18, 2012 – Sotera Wireless, Inc. announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the ViSi Mobile™ System, a new continuous vital signs monitoring system for use in hospitals. The clearance represents a major milestone in Sotera’s effort to develop a comprehensive wireless patient monitoring system, particularly for ambulatory hospital patients.
“Continuous vital signs monitoring is crucial to detecting early deterioration in a patient’s condition and facilitating early intervention or rapid response,” said Tom Watlington, Sotera’s chief executive officer. “The ViSi Mobile System will stretch the boundaries of patient monitoring by enabling clinicians to receive this information without limiting a patient’s freedom to move about the hospital.”
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 the hospital, like 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.
The 510(k) clearance applies to the first generation of the ViSi Mobile System capable of measuring and displaying all core vital signs. The small, wrist-worn device has been designed for use in ambulatory, non-ICU clinical settings and measures heart/pulse rate, 3- or 5-lead electrocardiography (ECG), oxygen saturation (SpO2), blood pressure, respiration rate and skin temperature.
Future generations of the system, now in development and not yet cleared by the FDA, are expected to include additional functionality, such as wireless transmission of data to computers or mobile devices for secondary viewing/notification and connectivity with a hospital’s electronic medical record (EMR) system. Sotera also expects to add novel sensing technologies to the system, including its patented cuffless non-invasive blood pressure (cNIBP).
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 <http://www.soterawireless.com> or by sending an email to firstname.lastname@example.org.