Sotera cleared to sell its full mobile-monitor system
Following its April go-ahead on Sotera Wireless’ ViSi mobile monitor, a stand-alone device for continuous observation of vital signs, the FDA has extended the 510(k) approval to the full ViSi system.
San Diego-based Sotera said the added feature is a wireless transmission function that will allow the devices to send data via WiFi to computers and mobile devices, as well as to hospitals’ EMR systems.
The company said it designed the product line, which consists of a device worn on the wrist and various non-invasive sensors placed elsewhere on the body, for use in ambulatory care settings. It added that it is testing sensing technologies for future versions.
San Diego-based Sotera said the added feature is a wireless transmission function that will allow the devices to send data via WiFi to computers and mobile devices, as well as to hospitals’ EMR systems.
The company said it designed the product line, which consists of a device worn on the wrist and various non-invasive sensors placed elsewhere on the body, for use in ambulatory care settings. It added that it is testing sensing technologies for future versions.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.