Devices & Diagnostics

No catheter, no cuff: FDA clears Sotera Wireless’ continuous noninvasive blood pressure technology

No more catheter, no more cuff for monitoring patient vital signs? Sotera Wireless announced the FDA has given 510(k) clearance to its continuous non-invasive blood pressure (cNIBP) technology, a new feature of its ViSi Mobile patient monitoring system. “For the first time clinicians can continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the […]

No more catheter, no more cuff for monitoring patient vital signs? Sotera Wireless announced the FDA has given 510(k) clearance to its continuous non-invasive blood pressure (cNIBP) technology, a new feature of its ViSi Mobile patient monitoring system. “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,” the company press release claims.

The new technology is meant to help manage treatment for patients with hypertension.

“Blood pressure is one of the most important vital signs and yet it is considerably undervalued, largely because most clinicians are limited to periodic cuff-based measurements,” Tom Watlington, Sotera CEO, said in a release. “By providing data collected around the clock without disrupting a patient’s sleep, we believe the ViSi Mobile System with cNIBP will help improve diagnosis and management of hypertension, saving lives and dollars.”

The ViSi Mobile System, a wrist-worn monitor that measures vital signs and is designed to be used in ambulatory, non-ICU clinical settings, and was FDA-cleared in 2012. The company also boasts partnerships with Intermountain Health and Reflectance Medical.

The company’s venture capital and strategic investors include Sanderling VenturesSafeguard ScientificsQualcomm VenturesEDBIIntel CapitalCerner CapitalDelphi VenturesIntermountain HealthcareAMR and West Health.