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: Keep reading>>