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.
“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.
“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.
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