9. Ceribell: $105.2 million (Non-invasive monitoring)

Ceribell makes a portable electroencephalogram (EEG) device for quickly assessing brain waves to flag suspected seizures in emergency rooms and intensive care units. The cloud-linked, AI-powered system offers around-the-clock brain monitoring and delivers results within five minutes.

The FDA cleared Sunnyvale, California-based Ceribell’s EEG system under a 510(k) submission in 2017. The system monitors brain activity using a headband and handheld recorder.

Last year, the FDA gave the system breakthrough device designation for detecting delirium, also referred to as acute brain failure. It’s an indicator of an ongoing brain injury — sometimes, the only indicator — and early detection and treatment is critical for patient care.

“Delirium happens frequently in the ICU and often remains under-diagnosed and under-treated,” Ceribell co-founder and CEO Jane Chao said in a news release. “We are excited to provide a tool that empowers bedside nurses and physicians to manage this challenging disease state with more precision. Modern critical care is moving beyond not only saving a life but also protecting the brain for a higher quality life as well.”

Ceribell’s EEG system is the first and only breakthrough-designated device for the screening and monitoring of delirium.

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