At long last, Sotera Wireless announced today it has received FDA 510k clearance for the entire ViSi Mobile System and will immediately commence sales to hospitals nationwide.
“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, in a press release from the company, adding:
“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.”
Sotera was awarded 510k approval earlier this year for the base unit and sensors that make up the core of the ViSi Mobile solution, but now they have formal approval of the full ambulatory solution featuring wireless data transmission via Wi-Fi.
Tom Watlington, Sotera's chief executive officer said
“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.”
I had the chance to interview Tom Watlington last November in the lead up to the 2011 mHealth Summit and found him to be an impressive and disciplined chief executive, with a comprehensive vision for building a company on the bleeding edge of digital health innovation. During the Summit I considered Watlington's performance in the high profile panel discussion in which he participated to be absolutely inspirational.
It has taken the Sotera team more than half a decade to get to this point, finally able to sell their products in the US. We will all soon see if they can execute on their strategy to quickly achieve scale and find an exit for their investors. I certainly wouldn't be betting against this team from Southern California.