TruBrain's Wearable Receives FDA Qualification

TruBrain recently received approval from the U.S. Food and Drug Administration (FDA) to move forward with its wearable device applications.

The milestone is one of the first steps on TruBrain’s path toward FDA approval of its Wearable as a medical device, which is designed to relieve stress.

The global wearable technology market was valued at $116.2 billion in 2021 and is expected to reach $265.4 million by 2026, growing at a compound annual growth rate of 18%, according to MarketsAndMarkets, which attributes the growth to increased demand for smart devices in healthcare.

TruBrain’s Wearable, built by neuroscientists, uses the vibrotherapy technology used in hospitals to soothe the user’s nervous system with safe, microsonic waves that increase blood flow, activate neurons and enhance neurotransmitter activity.

The unobtrusive, watch-like device can be worn on the wrist or ankle and is a safe and effective method to nudge the parasympathetic nervous response in healthy adults.

TruBrain Founder and CEO Chris Thompson has said that the company’s mission is to empower people to do their best thinking. Solving stress and anxiety problems will clear the way for people to focus, relax and get better sleep, he said.

About 33% of people report feeling extreme stress, and 77% experience stress that affects their physical health, according to the American Institute of Stress. In addition, 73% of people have stress that impacts their mental health, and 48% have trouble sleeping because of stress.

In addition to the Wearable still in development, TruBrain offers a line of nootropics blended to increase verbal fluency, avoid distractions and boost mental output. The products are made by neuroscientists trained at the University of California-Los Angeles and based on decades of clinical research and brainwave measurements.

TruBrain’s most popular products are its 1-ounce drinks, which its website describes as “personalized brain food.” The drinks are formulated to help with sleep, relieve anxiety and fight procrastination and distractions. The company also offers brain fuel in the form of capsules, bars and powder sticks.

The company reports $18 million in sales since its inception in 2012 and has been profitable since 2019.

TruBrain has raised $3.8 million from leading venture capital firms and more than 2,000 social investors.

TruBrain is raising money on StartEngine to support the development of the Wearable.

Shutterstock photo by vitstudio