West Health Blog: Sotera Wireless Gets 510(k) Clearance

West Health Blog: Sotera Wireless Gets 510(k) Clearance

Last week, we were really excited to see a portfolio company of the West Health Investment Fund hit a pivotal milestone in their mission when Sotera Wireless announced their Wireless ViSi Mobile Patient Monitoring System received a 510(k) clearance from the FDA to transmit patient’s vital signs.

In April, Sotera Wireless received its initial 510(k) clearance for its continuous vital signs monitoring system. This approval means their patient monitoring technology can now use wireless technology.

When people ask me what kinds of companies the West Health Investment Fund invests in, I point to technologies like this that can dramatically lower costs and change the way health care is delivered.

This small ViSi Mobile System consists of a small device, slightly larger than a sports watch, and comfortable non-invasive sensors that allow for freedom of movement. The system accurately captures and wirelessly transmits all core vital signs, including blood pressure, heart and pulse rate, ECG, SpO2, breathing rate and skin temperature.

The traditional systems for doing this are imposing, invasive and expensive.

We know that advancing cost effective models of care can impact costs and this innovative sensor technology can lower the cost and infrastructure associated with ICU-level monitoring.

This 510(k) clearance is one more important step in opening the door to providing hospital-quality monitoring to patients independent of where they are, and it also sends a positive message about the regulatory acceptance of wireless monitoring devices in even the most critical of health care settings.

We look forward to seeing the next steps from Sotera Wireless, as we think they are clearly heading in the right direction.

--Dr. Joe Smith
CMO and CSO
West Health