Sotera Wireless has officially received FDA 510k approval for ViSi Mobile, the comprehensive wearable physiological monitor the company has been developing for more than half a decade.
I interviewed Sotera Wireless CEO Tom Watlington shortly before the mHealth Summit last December, at which time he told me the company anticipated receiving FDA approval during the first fiscal quarter of 2012, and sure enough the final decision was issued just days before the quarter ended.
“We’re pleased to have received 510(k) clearance for the ViSi Mobile device,” said Watlington in reply to my request for comment regarding the FDA’s favorable decision. “It covers the wrist worn device and all of the traditional vital signs: HR/PR, Respiration, SpO2, NIBP, and skin temp. In addition, we offer 3 and 5 lead ECG. In the summer we intend to file a second 510(k) for wireless connectivity. The next few months will be devoted to establishing reference sites around the country and further field testing the system. By late summer, we will be in full launch. ViSi Mobile also received CE Mark in March.”
Interestingly, Watlington told me at the time of our interview the company had 60+ employees but not one of whom was focused on sales, though there can be little doubt Sotera has more than enough cash in the bank to put together an aggressive sales effort, having recently closed a $12.2 million Series D round.
According to the FDA 510k filing, Sotera is currently recruiting participants for an observational clinical trial of the ViSi Mobile system in the Denver-area. The study is under the direction of Principal Investigator David Ransom, MD of Avista Adventist Hospital, will include a sample size of approximately 1000 patients and is expected to be completed by the end of 2014.