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Soltera Wireless Gets FDA Approval for Continuous Blood Pressure Technology With ViSi Mobile Wireless Patient Monitoring

Posted Oct 16 2013 1:33am

The ViSi Mobile system is wrong on the wrist and can monitor all vital signs image(ECG, Heart/Pulse Rate, SpO2, Blood Pressure (cuff-based and now also cuffless on a beat-to-beat basis), Respiration Rate, Skin Temperature).  With being wireless, the data allows clinicians to monitor results on a remote viewing device, phone, tablet and so on.   It also has an alarm system if there is a radical change with the patient’s vitals.   The video below shows how it’s used with an ambulance picking up a patient with the doctor already seeing the vital signs long before the patient arrives at the hospital. 

From the website:

“In addition to the color touchscreen display on the patient-worn device, platforms such as desktop or tablet PCs can be utilized as remote viewing and notification devices. ViSi Mobile is able to wirelessly transmit data, leveraging existing hospital WiFi infrastructure, and is designed to provide information output in electronic form (i.e. EMR connectivity) as well as print-outs. In the future, the ViSi Mobile System will also include Sotera’s patient Posture / Motion as a “new vital sign.”

The device is in us at Palomar hospital in San Diego.  It is also a Cernerimage Care Aware partner.  It uses a standard WiFi connection and has full fail over capabilities in case of a hardware or software failure.  It has an HL-7 connection to receive patient demographic information and also can directly send information to a patient’s medical records.  There’s been a lot of talk about what kind of devices the FDA does need to approve and of course this is one of them as we are talking about a device reporting clinical information. 


Sotera Wireless, Inc. announced the U.S. Food and Drug Administration has cleared the Company's patented continuous non- invasive blood pressure (cNIBP) technology , a new feature of the ViSi Mobile wireless patient monitoring system.

According to the company, for the first time clinicians can continuously monitor all patient vital signs, including beat-to- beat blood pressure, without the use of a catheter or blood pressure cuff.
Physicians can use cNIBP measurements to betterimage manage patients with hypertension, commonly known as high blood pressure. Hypertension affects 67 million, or one in three, American adults resulting in a direct healthcare cost of approximately $50 billion.

The ViSi Mobile System is a wrist-worn monitor to measure all core patient vital signs: cNIBP, heart rate or pulse rate, electrocardiogram (ECG), blood oxygenation level, respiration rate and skin temperature, with the accuracy of systems used in hospital intensive care units. Wireless technology transmits vital sign data, enabling clinicians to monitor measurements on remote viewing or notification devices. 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.

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