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US regulators have issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that healthcare providers can use them to monitor patients remotely. "The leveraging of current non-invasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other healthcare facilities and healthcare professionals…and [ensure] other patients who require monitoring for conditions unrelated to COVID19 can be monitored outside of healthcare facilities," the FDA said Friday.
The policy, which is limited to the duration of the public-health emergency, applies to clinical electronic thermometers, electrocardiographs, cardiac monitors, electrocardiograph software for over-the-counter use and electronic stethoscopes, as well as devices for pulse oximetry, non-invasive blood pressure, and respiratory rate/breathing frequency.
Amy Abernethy, FDA principal deputy commissioner, stated that "during this public-health emergency, it is imperative that the FDA provide regulatory relief and adapt as the situation warrants to act upon measures to save lives."
According to the FDA, these devices have the potential to be connected to a wireless network through Bluetooth, Wi-Fi or cellular connection to transmit patient data directly to their healthcare provider. The agency noted that some of these devices "also have the potential to apply algorithms to transform a patient’s physiological parameters into a novel index or alarm that may aid a healthcare professional in the diagnosis of a particular condition or disease state/severity."
Also on Friday, Spry Health launched a clinician-led service in the US that uses its write-worn Loop device to improve at-home patient monitoring during the COVID-19 outbreak.
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