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FDA clears heart monitor for coronavirus patients using hydroxychloroquine

The Food and Drug Administration (FDA) today granted Emergency Use Authorization for a wearable biosensor called the VitalPatch, which can be used to monitor the heart rhythms of patients who have been treated for coronavirus with hydroxychloroquine.

The wearable patch adheres to a patient’s skin just above their heart and can be worn for seven days. It monitors for 22 different types of arrhythmia and fibrillation, as well as 11 other physiological signs, many of which coincide with symptoms of COVID-19, the disease caused by the virus, said Peter Van Haur, CEO of VitalConnect, maker of the sensor.

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The data is then streamed to a tablet that the patient and their health care team can monitor for any irregularities. The patient can then remain sequestered at home.

The drug hydroxychloroquine is commonly used to treat malaria, and has some dangerous side effects including what’s called “QT interval prolongation,” as well as life-threatening “arrhythmias.” Essentially, the drug can make your heart start beating irregularly and very quickly, which can lead to fainting spells, seizures, and even death.

In its letter of authorization, the FDA said that there are now “public health needs for vital sign and ECG monitoring for complications related to COVID-19 or its treatment,” since the “proposed treatments for COVID-19 include the use of drugs that can prolong QT intervals and may cause life-threatening arrhythmias.”

Based on this, the FDA has announced that VitalPatch “may be effective” for remote heart monitoring for patients that have undergone treatment for COVID-19 using drugs that can affect their heart.

“When COVID 19 hit, there was a large need for a few different things. One was to quarantine COVID patients, but also to still be able to monitor them in a remote fashion,” Haur told Digital Trends.

VitalConnect launched its patch around a year and a half ago, Van Haur said, and has about 100,000 patches on the market, including in nursing homes and assisted care facilities, as well as pharmaceutical companies that are running trials on new drugs.

For several weeks, President Donald Trump has pushed hydroxychloroquine as a possible treatment for COVID-19.

Studies have been inconclusive about the effectiveness of the drug, but some doctors have begun using it to treat coronavirus symptoms. The FDA recently advised people not to treat themselves with the drug without a doctor’s supervision.

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