On June 8, the Food and Drug Administration (FDA) expanded on guidance it released in March that allows additional medical devices to be utilized for remote monitoring for new indications without specific market clearance. In addition to the originally included electrocardiograph (ECG), cardiac monitor, and ECG software device types, the updated guidance would also include cardiac monitor with cardiotachometer and rate alarm, telephone ECG transmitter and receiver, and several electroencephalograph devices. While the FDA typically allows smaller changes to devices or the expansion of their use to cases that go beyond their claimed indications, also known as “off-label” use, given the need during the COVID pandemic to reduce patient exposure through face-to-face care, the FDA is issuing this expanded guidance to use its discretion to make such expanded uses easier for patients and providers. These expansions will last through the duration of the HHS-declared COVID public health emergency, which began Jan. 27
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When a person is newly diagnosed with any disease or serious medical condition, they are often flooded both with anxiety and unfamiliar medical terms. The weight of the unknown can overwhelm. Patients diagnosed with heart valve disease hear words like: stenosis, regurgitation, heart failure, valve repair or replacement, blood thinners, tissue or mechanical valves, open heart surgery or minimally invasive procedure. And that list doesn’t even include any of the tests! Feeling unsure while navigating decisions about treatment is completely normal. If you or a loved one is in this situation, you’ve earned the right to feel anxious.