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.

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