EnsoData cleared by FDA for sleep software

EnsoData, a Madison-based health technology company, has been cleared by the FDA for its EnsoSleep software.

Chris Fernandez, the company’s CEO and co-founder, says gaining that clearance “involved a ton of nonclinical and clinical testing of software,” since the company was founded in 2015.

“We really started it after closing our $550,000 seed funding round last April,” Fernandez said, adding it took about 4 months to write all 800-or-so pages of the proposal document.

EnsoSleep, the company’s first product, is a software system that plays a role in sleep studies. It takes data from sensors and devices that measure breath, heart rate and other variables while the patient is sleeping, integrates those results, and analyzes them much more quickly than a person could.

Fernandez estimates manually scoring a single sleep study could take anywhere between 45 minutes to 2 hours.

“A big advantage of using cloud computing is you automatically scale computational resources as needed, based on the amount of data coming in,” he said.

That means whether EnsoSleep’s software gets data from 10 studies or 1,000 studies, results can be delivered in eight to 10 minutes — regardless of the volume of data.

“Really, it’s just about realizing the benefits to sleep centers to the greatest extent possible,” he said. “Get the most out of the system, increase productive capabilities, and increase patient access.”

The company, which came out of gener8tor’s gBETA program and the Y Combinator accelerator, has future plans to sell its software on a subscription basis to independent sleep centers and big health systems. Moving forward, Fernandez says he is focused on expanding sales and support, adding to the three-person team of engineers that currently operates EnsoData.

“Next step: grow, grow, grow,” he said. “We’re looking to convert that first batch of trial customers to paid subscription customers.”

See an earlier story on Ensodata: http://wisbusiness.com/index.Iml?Article=368901

–By Alex Moe