Denver-based Biointellisense Inc. has unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. The device, coupled with HIPAA-compliant data services, permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state.

"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 convenience of the Biobutton will support a range of clinical use cases for RPM [remote patient monitoring] reimbursement and mass market use to enable safe return to work or school."

Mault told BioWorld that the company wanted to go ahead and announce the button now ahead of its summer availability to let people know it exists and take preorders. That’s so it will be able to meet demand. “So, we have the FDA clearance to go to market, we’re just gearing up the manufacturing,” he confirmed.

Busy time

This year has proven to be a busy one for Biointellisense. In January, the company said it had gained the FDA’s nod for its Biosticker on-body sensor for scalable remote care. The solution is designed to be worn on the upper left chest and can monitor respiratory rate, heart rate at rest and skin temperature. It also can monitor for symptomatic events.

In March, the company reported that the offering permits remote data capture of symptomatic events and multiparameter biometrics for complex care and symptoms directly associated with COVID-19.

March also saw the introduction of the 5G-enabled Biohub connectivity gateway to the company’s medical grade data-as-a-service platform.

This preconfigured connectivity gateway is built with a Qualcomm 5G chip set for auto-detection of the Biosticker on-body sensor, along with compatible third-party medical devices. The company said it enables near real-time encrypted data transmission of minute-level vital signs to the Biointellisense Biocloud for algorithmic analysis and reporting.

Subsequently, Mault told BioWorld in April that there was a host of companies looking to team up with his organization, including large academic medical centers, national health insurance payers, employer groups, as well as pharma and device companies.

“Without debate, the COVID crisis has dramatically accelerated the adoption of remote patient monitoring by health systems, providers, and payers,” he added. “Biointellisense will continue to innovate and lead the effortless, cost effectiveness, and beneficial outcomes of medical-grade wearables and clinical intelligence that will make remote patient monitoring a permanent and routine component of health care delivery.”

Indeed, with the pandemic raging on, he told BioWorld this week that the company has been contacted by a range of industries – from automotive, to tech, to retail, to nuclear power, to pharma – to monitor mission-critical employees.

Alternative to measuring spot temperature

Trying to pinpoint sick employees is a challenging task. The problem with measuring spot temperature of employees entering the building is that if they have a bad fever, they are at the workplace and could have contaminated other people already. Also, there is a chance that such a measurement could miss a sick employee who may be between fevers as a result of taking medication. “You’re putting all your eggs in one clinical parameter that doesn’t necessarily tell you the whole picture,” Mault added.

His company is looking to add tools to the fight.

“Imagine having a scenario with a Biosticker and now the Biobutton – we’re going to make it ridiculously easy and inexpensive to be able to track and monitor a continuous temperature tracing.” That will allow for the monitoring of a person’s temperature and corresponding parameters related to COVID-19, such as respiratory rate, coughing and heart rate. Patients could know before leaving their homes whether they are cleared for work.

“We have dozens of hospital systems and health provider groups starting to use the Biosticker this month just for health care workers and monitoring them,” Mault said.

Biobutton vs. Biosticker

So, what is the difference between the two offerings? “The button, number one is created for simplicity, even beyond what the Biosticker has. So, it’s smaller, [and] it’s even thinner.” The battery life also is longer, Mault added.

“It’s not measuring all of the things that the Biosticker measures, and it’s not measuring it as frequently,” he added. As a result, the sticker is more appropriate for a person coming home from the hospital and needs very close monitoring. “So, the Biobutton is … saying, what are the basics? And how do make that really, really invisible to the user, so they barely realize they’re wearing it, and yet it’s transmitting this continuous data.”

With that said, both offerings are affordable and could serve children and employees. “We already have school systems reaching out to us,” he noted, because teachers are concerned about heading back to the classroom in the fall and potential exposure. The same applies to the students as well.

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