toSense’s CoVa Monitoring System 2, a remote patient monitoring necklace that tracks vitals and cardiac fluids, has received a second FDA clearance.
The new clearance will allow the company to update the software to add a new feature that measures stroke volume and cardiac output to the orginal product. The clearance also lets the device connect to a mobile application that allows medical professionals to remotely view measurement data and single-lead ECG wave forms.
“With our recent FDA clearance for stroke volume and cardiac output measurements, clinicians will now have daily, remote access to these important hemodynamic properties, taken quickly and easily by the patients themselves,” Susan Pede, Vice President of Operations at toSense, said in an email to MobiHealthNews. “We believe that this will assist in many patient populations, including those suffering from [congestive heart failure], those recently discharged from the hospital, and those waiting to see a doctor. Combined with the other medical-grade measurements made by our system, including heart rate, heart rate variability, and respiration rate, physician will be able to monitor patients’ cardiac status more efficiently.”
The first version of the CoVa system got FDA clearance in May of 2015. The CoVa 1 tracked a number of vital signs including heart rate, heart variability, respiration rate, skin temperature, and thoracic fluid levels.
The company said that unlike weight, which is a late indicator of potential hear failure, fluid level, stroke volume, and cardiac output are all relatively early indicators.
It takes less than five minutes for the large necklace to get the measurements and vitals, according to the company. The information is then sent from the necklace via Bluetooth and is forwarded to a web-based system over WiFi or cellular networks. The web-based system can forward the information to an external customer system, EHRs, or remote monitoring portals.
The company said the necklace can be used for several different applications including remote patient monitoring, post-discharge monitoring, and clinical monitoring.
At the time of the first CoVa's launch, the FDA had already cleared another product, the Piix sensor, which also monitored cardiac fluids. The Piix sensor was originally released by Corventis, a company which has since been acquired by Medtronic.
In 2015, toSense displayed two new prototypes at a BIO event in Pennsylvania — one for a handheld device and another for a weight scale-like floor pad. Both of the devices aimed to measure the same vital signs and congestive heart failure predictors as Cova. However, the company is no longer working on those products, instead continuing with the CoVa product line.
“CoVa 2 is transformational in delivering high-acuity monitoring outside of the hospital. The system gives clinicians remote access to important, actionable data,” Matt Banet, President and Chief Scientific Officer at toSense, said in a statement. “The system’s low price point allows universal access to a new, exciting wearable that could be a critical component of modern healthcare systems.”