The FDA has granted an Emergency Use Authorization (EUA) to VitalConnect that allows its VitalPatch wearable sensor to further monitor patients undergoing COVID-19 treatment.
As per the agency's letter of authorization, providers may use the remote-monitoring device in a hospital setting to spot changes in patients' QT interval, which may be dangerously prolonged by experimental drug treatments such as hydroxychloroquine or chloroquine.
Part of VitalConnect's broader Vista Solution continuous-monitoring platform, VitalPatch is a disposable adhesive wearable that can be used for seven days straight. It's capable of tracking eight vital signs (or 11 with the aid of compatible third-party devices) in real time, such as single-lead ECG, heart rate and heart rate variability, activity, and respiratory rate.
WHAT'S THE IMPACT?
In making its decision, FDA said that it considered the need for vital sign and ECG monitoring among those at risk for complications related to COVID-19 or its potential treatments. The EUA for VitalConnect fills a need for remote patient-monitors capable of detecting QT interval changes, the agency wrote, and does so while potentially reducing healthcare providers' exposure to the virus.
"COVID-19 presents a myriad of symptoms and clinicians need access to medical devices that allow them to monitor and manage those symptoms in real-time in order to create the most appropriate treatment plans for each individual," Dr. Joe Roberson, CMO of VitalConnect, said in a statement. "The enhancement of the VitalPatch receiving [EUA] for QT-interval detection will enable this platform to further support clinicians who are on the frontlines of treating this virus."
THE LARGER TREND
The FDA has had its eye on remote vital-sign monitors since mid-March, when it announced a temporary policy that would expand the use of certain connected non-invasive devices throughout the course of the COVID-19 public health emergency. Since then, VitalConnect, Livongo, Abbott and other digital-health mainstays announced plans to expand access to their connected health-monitoring products.
And connected vitals monitors haven't been the only types of digital health products to benefit from relaxed regulatory guidelines. Ophthalmologic devices, digital psychiatric treatments and telehealth at large have all been provided an opportunity to reach more patients throughout the public health crisis.
ON THE RECORD
"As we learn more about the novel coronavirus, the VitalPatch and Vista Solution platform can make a big impact on the treatment of the many people suffering across our nation," Peter Van Haur, CEO of VitalConnect, said in a statement. "Continuous, real-time monitoring enables next-level care and efficiency in the hospital and in post-discharge settings that will help clinicians treating patients on the frontlines today."