Early this week cardiac-focused digital health company Eko scored a temporary Emergency Use Authorization (EUA) for its ECG low ejection fraction tool, which can be used to help clinicians spot cardiac complications associated with the novel coronavirus.
Providers are able to use the tool in order to get an assessment of Left Ventricular Ejection Fraction, a measure which providers can use to determine preexisting conditions that could impact someone with coronavirus, as well as any complications arising from care.
In the FDA's letter of notification, Denise Hinton, Chief Scientist of the FDA, wrote that to date there are no FDA-approved devices to screen for cardiac dysfunction in COVID-19 patients.
“There is published evidence that patients with cardiac comorbidities are at substantially increased risk for complications from COVID-19, and COVID-19 may exacerbate or introduce cardiac comorbidities which is associated with higher risk of in-hospital mortality,” Hinton wrote. “Based on published evidence, there has been a recognition that screening for cardiac conditions is an important part of managing patients with confirmed or suspected COVID-19.”
WHY IT MATTERS
An increasing body of evidence is linking COVID-19 to heart damage, according to Johns Hopkins Medicine. The CDC also notes that individuals with severe heart conditions are at an increased risk for severe illness from COVID-19.
“Early detection of heart failure patients can better inform treatments for these individuals at higher risk for severe illness from COVID-19,” Connor Landgraf, CEO and cofounder of Eko, said in a statement. “With the FDA’s Emergency Use Authorization, Eko will be able to offer its low [ejection fraction] screening at Mayo Clinic immediately, the first step in expanding the offering to other providers on the Eko platform.”
THE LARGER TREND
In March the HHS Secretary greenlighted an EUA for ventilators and other medical devices related to treating the virus. And just last week, VitalConnect's VitalPatch received its own EUA for cardiac monitoring during the COVID-19 health emergency. However, it is important to note that unlike and FDA clearance, these authorizations are temporary.
Eko has been hearing other good news from the regulator as of late. In January it scored a 510(k) clearance of its atrial fibrillation and heart murmur-detection algorithm. Additionally, while Eko Core first got the FDA greenlight in 2015, its most recent version was released in 2019.