The U.S. FDA has OK’d expanded labeling for Physiq Inc.’s continuous remote monitoring system, Pinpointiq, for use during the COVID-19 pandemic. The machine learning-based platform, including Multivariate Change Index (MCI), will allow clinicians to track physiologic changes in homebound, quarantined or high-risk patients with confirmed or suspected COVID-19 – freeing up hospital beds for the most severe cases and reducing exposure of doctors and nurses to the highly contagious disease.

The FDA-sanctioned labeling underscores the growing role telehealth can play in the nationwide outbreak.

Gary Conkright, Physiq’s CEO, said the company reached out to FDA for clarity about pitching Pinpointiq for COVID-19 patient monitoring, and that the agency quickly issued guidance including the product codes necessary to make those claims.

Intense need

“Since the issuance of the guidance, our phone has been ringing off the hook,” Conkright told BioWorld, adding it is his understanding that the expanded labeling will be tied to this national emergency.

“Our entire health care infrastructure is about to become completely overwhelmed by COVID-19. We will have more patients than hospital beds, and our only option is to find ways to better care for patients at home,” Conkright said. “With clinical-grade wearable sensors and our proprietary, FDA-cleared analytics, we are providing hospitals with personalized physiologic visibility into their homebound high-risk COVID-19 patients.”

Physiq’s cloud-based technology continuously collects and processes data – such as temperature, heart rate and respiration rate – from wearable biosensors using the company’s machine learning-based algorithms and AI analytics. If a patient’s vitals veer from their baseline, indicating that their condition is worsening, a clinician is immediately alerted who can determine if any action is needed.

The system is easy to use. Patients receive a kit with the sensors, other components and a phone for transmitting data. The data is collected and transmitted directly from the patient’s home, eliminating the need for face-to-face contact with a clinician.

Prior experience in Ebola epidemic

The company already has evidence showing the platform’s potential to avert hospitalizations. In a recent Veterans Administration study, Physiq’s platform gave researchers up to 10 days warning of physiologic changes in heart failure patients that would require hospitalization or an emergency room visit, providing time for clinicians to intervene and avoid readmissions.

Physiq also has prior experience monitoring patients during epidemics, having applied Pinpointiq in the Ebola outbreak in Sierra Leone in 2014. “It was a similar type situation – very contagious, and having a clinician going to a quarantined area every two hours to take vitals exposed them” to the pathogen, Conkright said. Pinpointiq provided clinicians with advance notice if a patient’s condition deteriorated

Tending to Ebola patients also required providers to use protective masks and garments, products that are in short supply in the current pandemic.

Conkright believes the platform can have an impact with COVID-19 as well. “It expands the leverage that each of these doctors and nurses has. They can monitor maybe 150 patients instead of four … and apply their skills and resources exactly where they need to be,” he said. It also reduces PPE usage and puts fewer health care workers at risk of exposure and needing to quarantine.

While nobody knows just how bad the U.S. outbreak will eventually get, Physiq believes its capacity and supply chain will support the foreseeable demand. “We don’t think there’s any limit to our platform process and present data, and we’re staffing up to be able to ship and educate and service our customers,” Conkright said.

Crisis fueling telehealth demand

Demand for telehealth services has risen sharply as doctors and hospitals tell patients who are not seriously ill to stay at home, and as people practice social distancing to slow the spread of the virus. Teladoc Health Inc., of Purchase, N.Y., reported a 50% uptick in daily virtual medical visits in the week ending March 13. The demand has increased as a number of health plans have waived consumer cost sharing and public health officials have urged people to use available virtual care services.

Meanwhile, Miramar, Fla.-based MDlive said on its website that it is experiencing longer-than-normal wait times due to the COVID-19 pandemic, and noted that its doctors cannot currently order tests for the disease.

Last week, Healthcall LLC, of Crown Point, Ind., released a COVID-19 telehealth screening and monitoring application, with the aim of helping paramedics care for more patients more quickly.

And Los Angeles-based Scanwell Health is planning to broaden COVID-19 testing with at-home tests it recently licensed from Innovita Biological Technology Co. Ltd., of Hebei, China. The tests should be available in the U.S. within six to eight weeks of securing FDA emergency use authorization, Scanwell said.

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