Sotera Wireless has received yet another FDA 510(k) clearance for its ViSi remote patient monitoring system, this time for its novel continuous noninvasive blood pressure (cNIBP) monitoring software. The technology, which enables continuous blood pressure monitoring without a cuff or catheter, has been part of Sotera's pitch from the beginning, but was not included in the company's April 2012 device clearance or its August 2012 full system clearance.
"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's CEO, said in a statement. "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."
Gunnar Trommer, Sotera's VP of Marketing, told MobiHealthNews that the company submitted the technology to the FDA in March and has been working closely to get it cleared. He said the company intentionally saved this system for last because the other two devices needed to be cleared first as predicate devices. The patented system measures the user's pulse in the thumb and the chest and calculates blood pressure based on the time it takes blood to flow from one point to the other. Because everyone's blood flows differently, the device first has to be calibrated for each individual with a traditional cuff measurement. The method has been compared to catheter-based measurements in clinical trials and was accurate within 5 mmHg.
Even without the continuous blood pressure monitoring, Sotera has managed to build up a significant user base for its continuous monitoring platform. Intermountain Healthcare in Utah signed a clinical partnership with Sotera in May, joining existing users Scripps Health, Palomar Pomerado Health, and NASA. The new technology, which is a software update only to the existing platform, will be soft launched with these existing partners over the course of the quarter and made available to new customers in the beginning of 2014, according to Trommer.
The big practical difference for those customers is that nurses will no longer have to wake patients in the night for periodic blood pressure checks, which both reduces the workload on nurses and improves the patient experience. But the continuous data itself is also valuable -- it could yield new insights about hypertension and alert doctors more quickly to a problem with a particular patient.