Late last month, the FDA began giving developers of remote patient monitoring devices some extra leeway when it comes to making marketing claims, allowing them to pitch their use to hospitals responding to the COVID-19 crisis.
The ultimate goal is to move as many patients as possible out of the clinic that don’t need immediate, critical care. For example, a person who tested positive for the novel coronavirus but has only mild symptoms could stay at home and have their temperature, respiration and heart rates tracked wirelessly for signs of progression.
Now, LifeSignals announced that it is fast-tracking its single-use biosensor patch for COVID-19 patient monitoring. Self-affixed on the chest for five days, the showerproof device records a person’s vital signs, movement and the heart’s electrical activity with a two-channel ECG.
If stronger symptoms develop, the device and its data platform can alert healthcare workers to take additional action, while cumulative vital sign data could be used to identify geographical COVID-19 hot spots.
The company also plans to roll out an updated version of the patch that includes blood oxygen saturation tracking, slated for this June, for monitoring patients recovering in intensive care units and clearing them to be moved to other wards or off-site.
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"As soon as the serious nature of the COVID-19 outbreak became apparent, we started investigating where our wireless biosensor technology could help,” said LifeSignals co-founder and CEO Surendar Magar. “We identified two key areas where healthcare systems are choked—consumers calling in about symptoms they are experiencing and lack of critical care hospital beds—and have designed these two biosensor patches which are suited for mass production.”
LifeSignals aims to move 1 million units in the next few months, Magar told FierceMedTech, under a mass-market oriented business model targeting a variety of service providers.
Elsewhere, former FierceMedTech Fierce 15 winner Spry Health launched a clinician-led monitoring service employing its previously FDA-cleared Loop wearable. The wrist-worn device remotely tracks heart rates, pulse oximetry and breathing.
“After talking to dozens of healthcare leaders over the past few weeks, it is clear many organizations are nearing their maximum capacity due to the large influx of patients showing up to emergency departments, often without meeting the necessary criteria for testing set by the CDC,” said Pierre-Jean Cobut, Spry’s co-founder and CEO.
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“Clinicians can focus on the patients that need critical care, while we help monitor high-risk populations and intervene in advance of an emergency when early signs of deterioration are detected,” Cobut added. “The last thing we need now is to continue to flood the ED with avoidable visits, and possibly increase exposure to COVID-19, when care can be delivered remotely in the patient’s home.”
Patients with deteriorating symptoms will be contacted by telephone, treated remotely if possible or directed to the appropriate level of local care, the company said.
Other companies, such as UTM:Healthcare, have begun incorporating Bluetooth-enabled thermometers into the use of smartphone apps to keep people in touch with their doctors.
Meanwhile, ObvioHealth launched a virtual COVID-19 patient registry to track symptoms and immune responses across the general population.
The study will follow individuals for six months, detailing medical histories and risk factors associated with the infection and daily developments in order to provide insights for global health policy. The project includes plans to ship fingerstick blood tests to assess antibody and immune responses once they become available in the U.S., the company said.