Sotera Wireless

About Sotera Wireless

Sotera Wireless, now also operating as Sotera Digital Health, is a medical device company established in 2004 with a focus on enhancing patient safety through continuous surveillance monitoring. The company's business model centers on the development, marketing, and sale of its ViSi Mobile® Patient Monitoring System to healthcare providers, including hospitals and acute care facilities. Revenue is generated through the sale of these systems and associated support agreements. A significant milestone was achieved in March 2020 when Sotera was awarded a group purchasing agreement with Premier Inc., providing access to thousands of member hospitals. The company has also secured agreements with other group purchasing organizations like HealthTrust.

The core of Sotera's offering is the ViSi Mobile System, a wearable, body-worn platform designed to provide continuous, ICU-level monitoring for patients in general care settings, where vital signs are often checked only intermittently. The system monitors a comprehensive set of vital signs, including heart rate, 3- or 5-lead ECG, oxygen saturation (SpO2), respiration rate, skin temperature, and importantly, continuous non-invasive blood pressure (cNIBP), a feature that differentiates it from traditional cuff-based measurements. Data is transmitted wirelessly in real-time to clinicians via desktop PCs, tablets, or smartphones, and the system can be integrated with a hospital's electronic medical record (EMR) systems, such as Cerner's iBus. This constant surveillance allows for the early detection of patient deterioration, aiming to prevent adverse events and improve outcomes without restricting a patient's mobility. The product has received multiple 510(k) clearances from the U.S. Food and Drug Administration (FDA), beginning in 2012 for the initial system and later for enhancements like arrhythmia detection and cNIBP.

The company's history includes significant challenges and strategic shifts. In September 2016, Sotera Wireless filed for Chapter 11 bankruptcy protection, citing technical and performance issues with its device that delayed new features and reduced revenue, as well as costly litigation involving trade secret allegations from rival Masimo. The company successfully emerged from bankruptcy in July 2017 after securing nearly $32 million in new financing. The legal disputes with Masimo continued, culminating in a May 2024 settlement where Sotera and its partner Hon Hai Precision Industry Co. (Foxconn) agreed to cease selling the ViSi Mobile device and related products. PitchBook data indicates that Sotera was acquired by Foxconn Technology on July 11, 2022. The company, founded by Matthew Banet, has been led by CEO Tom Watlington and later Dr. Devin McCombie.