FDA-approved monitor measures blood pressure non-invasively

The U.S. Food and Drug Administration has approved a patented continuous non-invasive blood pressure (cNIBP) technology from San Diego-based Sotera Wireless, according to a company announcement.

A new feature of Sotera's ViSi Mobile wireless patient monitoring system, cNIBP measurements enable doctors to better manage patients with high blood pressure. 

The company claims that the ViSi Mobile System is the first wrist-worn monitor to measure all core patient vital signs--cNIBP, heart rate or pulse rate, electrocardiogram, blood oxygenation level, respiration rate and skin temperature--with the accuracy of systems used in hospital intensive care units. And, for the first time, physicians can now continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the use of a catheter or blood pressure cuff. 

"Numerous studies point to the benefits of beat-to-beat blood pressure monitoring, but obtaining accurate continuous data currently requires catheter insertion, exposing patients to discomfort and risk of infection," reads the announcement. "Sotera's cNIBP technology maximizes comfort and safety by obtaining measurements without invasive procedures or the frequent use of a blood pressure cuff. In studies comparing the clinically validated cNIBP technology with invasive arterial line procedures cNIBP technology demonstrated a bias of less than 5 mmHg."

Wireless technology transmits vital sign data, enabling clinicians to monitor measurements on remote viewing or notification devices. In addition, the system incorporates safety features, such as an advanced alarm management system that notifies clinicians of unfavorable changes in a patient's condition, enabling early intervention if needed.

Palomar Medical Center in Escondido, Calif., was the first hospital in the country to use a wrist-worn device to continuously monitor patients' vital signs. The FDA-approved ViSi Mobile System from Sotera is the technological enabler that transmits patient data to nurses in the hospital, providing them with around-the-clock surveillance of key vital signs. In February, Palomar Medical Center "went live" with the ViSi system on a general surgical floor for post-operative, low acuity care patients.

To learn more:
- read the announcement