Sotera nets FDAs OK on wearable continuous-monitoring system
Sotera Wireless has received 510(k) clearance to sell a new, wrist-worn system for continuous monitoring of vital signs, called ViSi, which has been designed for use in ambulatory, non-ICU clinical settings and measures heart/pulse rate, 3- or 5-lead electrocardiography, oxygen saturation, blood pressure, respiration rate and skin temperature.
Continuous monitoring systems, which can assist in identifying emerging problems, are typically used only in the ICU or other high-acuity areas of the hospital. In lower acuity areas, which host 60 to 70 percent of hospitalized patients, vital signs are typically collected via spot checks that are conducted at intervals of four to six hours, according to a Sotera statement.
The San Diego-based company said it hopes to equip future generations of the product line with additional functionality, including wireless data transmission and EMR connectivity. Sotera said it also expects to update the sensing technologies to the system to include its patented cuffless non-invasive blood pressure software.
Continuous monitoring systems, which can assist in identifying emerging problems, are typically used only in the ICU or other high-acuity areas of the hospital. In lower acuity areas, which host 60 to 70 percent of hospitalized patients, vital signs are typically collected via spot checks that are conducted at intervals of four to six hours, according to a Sotera statement.
The San Diego-based company said it hopes to equip future generations of the product line with additional functionality, including wireless data transmission and EMR connectivity. Sotera said it also expects to update the sensing technologies to the system to include its patented cuffless non-invasive blood pressure software.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.