COVID-19: LifeSignals, VitalConnect Get Green Light For ECG Remote Monitoring

BY MARION WEBB

Executive Summary

Two California-based ECG remote monitoring companies see rising demand for their solutions during the COVID-19 crisis.

Two California-based makers of electrocardiogram (ECG) remote monitoring patches have been given the go-ahead to sell their devices in key markets.

Fremont-based LifeSignals said it received the CE mark for its Biosensor Patch 1A, clearing the way for marketing in Europe, while San Jose-based VitalConnect said it obtained emergency use authorization (EUA) from the US Food and Drug Administration to bring its ECG VitalPatch into hospitals for monitoring COVID-19 patients.

Under the EUA, VitalConnect’s VitalPatch will be used to detect changes in the QT interval in COVID-19 patients who are being treated with drugs such as hydroxychloroquine or chloroquine. These drugs, especially when combined with azithromycin, may cause life-threating arrythmias or irregular heartbeat.

In a letter to VitalConnect, the FDA concluded that “based on bench testing and reported clinical experience,” the VitalPatch may be effective for remotely monitoring and detecting QT interval changes in COVID-19 patients who are 18 years or older and taking drugs; but cannot be used for critical care patients. Conventional ECG measures QT interval on a 12-lead device during various time points by health care workers entering the room.

“Our vital sign monitoring is especially useful for COVID-19 patients either in or outside the hospital while our cardiac monitoring solution is ideal for arrhythmia detection,” Peter van Haur, CEO of VitalConnect told Medtech Insight. He added that VitalConnect had more than 10,000 patches ready for shipping and has the capacity to build “tens of thousands a month.”

The VitalPatch already received clearance from the FDA as a Class 2 wearable biosensor for monitoring 11 physiological vitals – body temperature, heart rate, heart variability, respiratory rate, blood oxygen saturation levels, single-lead ECG, body posture, fall detection, activity such as steps, blood pressure and weight – in real time, continuously for seven days. The EUA is temporary and for treating COVID-19 patients.

In February, VitalConnect partnered with CorVitals to provide patient monitoring and heart rhythm analysis in a comprehensive platform called Vista Solution 2.0. The company sells its patches to hospitals, long-term care facilities and for monitoring patients at home after they have been discharged from the hospital. The patch is designed to wirelessly transfer data to a thirdparty device and can be integrated with an electronic medical record system, said van Haur.

European Launch for LifeSignals

LifeSignals said it will start marketing its Biosensor Patch 1A in Europe on 18 May through a network of partnerships with OEMs and telehealth software providers to specialist hospital facilities.

The interoperable biosensors can be “whitelabelled,” customized and integrated into client systems according to their requirements, the company said. The majority of European clients that are in discussions for integrating the sensors are located in the UK and Italy. The estimated cost of the BioSensor is $20-$45, depending on features and functionality, LifeSignals said.

The company also plans to submit EUA-supporting documents with the FDA this month to market the patch and app either directly to consumers or through a third-party provider. It has already received FDA clearance for a two-lead and heart monitoring patch for hospital and ambulatory use.

LifeSignals has had a limited introduction of its FDA-cleared patch thus far, but has also landed CorVitals as one of its customers, Surendar Magar, CEO and co-founder of LifeSignals told Medtech Insight earlier.

BioButton

Meanwhile, another remote monitoring device maker, BioIntelliSense announced the introduction of its new BioButton to remotely monitor temperature, respiratory rate, heart rate at rest, body position, sleep and activity for 90 days on a single, disposable on-body sensor.

The Denver, CO-based start-up received FDA clearance in 2019 for the BioSticker, a barbellshaped device that sticks to a patient’s chest for up to 30 days continuously.

“The introduction of the BioButton device, in combination with the BioMobile applications and enterprise triage dashboards, represents a significant advancement in making continuous medical-grade monitoring reliable, effortless and cost-effective,” said James Mault, CEO of BioIntelliSense. The company teamed up with UCHealth to begin clinical testing of the BioSticker starting with postoperative and diabetic patients.