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ARTICLE

FDA Grants Emergency Use Authorization to Heart Biosensor for COVID-19 Patients

MAY 05, 2020 | GRANT M. GALLAGHER
FDAThe US Food and Drug Administration (FDA) has granted Emergency Use Authorization status to a wearable bionsensor for cardiac monitoring in coronavirus disease 2019 (COVID-19). The authorization was granted to VitalConnect.

The VitalPatch is now authorized to monitor patients for changes in QT interval. Investigational drugs being administered to COVID-19 patients, such as chloroquine and hydroxychloroquine, can cause prolongation of QT intervals and life threatening arrhythmias. SARS-CoV-2 infection also has been observed to have some effect on the heart.

The device is a disposable, band-aid sized wearable patch, each with a seven-day battery life.

The technology was developed in 2011. Joe Roberson, MD, Chief Medical Officer of VitalConnect, said in a statement that the patch would assist those on the frontlines of 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," Roberson said.

The sensor can be used with other devices to measure 11 physiological vitals in real-time including body temperature, heart rate variability, and blood oxygen saturation levels.

The impact of COVID-19 on the heart has been observed in several studies.

Available data suggest 2 apparent patterns of myocardial injury associated with COVID-19. The first indicates a rise in hs-cTnI—as well as D-dimer, ferritin, IL-6, and lactate dehydrogenase—suggest this is more indicative of a cytokine storm or secondary hemophagocytic lymphohistiocytosis rather isolated myocardial injury. The second, which occurs in patients with predominantly cardiac symptoms, is more indicative of potential viral myocarditis or stress cardiomyopathy—they reference 3 reports to evidence this point.

In another study of approximately 400 patients conducted by Wuhan University, it was discovered over half of patients (51.2%) who suffered cardiac injury died compared to just 4.5% of patients without cardiac injury.
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