Soberlink Receives FDA Clearance for Medical Use

July 13, 2016
|   updated:
January 18, 2024

HUNTINGTON BEACH, CALIF. – Soberlink, the leader in real-time mobile-breath sobriety technology, today announced that the Soberlink Breathalyzer has received 510(k) premarket clearance from the U.S. Food and Drug Administration (FDA) for medical use by healthcare providers to remotely measure alcohol in human breath, for the purpose of aiding in the detection and monitoring of alcohol consumption in those who suffer from alcohol use disorders.

Soberlink and Sober Sky Web Portal act as an accountability tool that allows recovering individuals to conveniently and discreetly share blood alcohol content (BAC) results with their treatment providers and recovery circle from almost anywhere in the world. Soberlink has worked for over five years with the top treatment facilities and addiction experts to develop a protocol for using the Soberlink System in clinical monitoring of alcohol use disorders.

“It is great to see the FDA clearing a remote monitoring device for recovery management by healthcare providers. Remote clinical monitoring has been used successfully in the treatment of other chronic diseases such as diabetes and hypertension to monitor key disease progression indicators and has provided the kind of information that healthcare professionals can use to adjust and improve their patients’ care,” says Tom McLellan, Founder and Chairman of the Board of Directors at Treatment Research Institute. “It is about time that we have the same kind of technology to provide personalized, continuing care for alcohol use disorders.”

The longer a person stays involved with consistent monitoring, the better the long-term outcome. The traditional standard of care for alcohol monitoring has been urinalysis testing. With the Soberlink Cellular Device and Sober Sky Web Portal, testing is no longer confined to a laboratory environment. The flexibility of the Soberlink System and partnership with Verizon Wireless empowers individuals to test from nearly anywhere and at any time.

“According to studies from the Centers for Disease Control and Prevention, nearly 88,000 people die from alcohol-related causes annually, making alcohol the fourth leading preventable cause of death in the United States,” stated Brad Keays, Founder and CEO of Soberlink. “Further attesting to its prevalence, the Foundation for a Drug-Free World cites that out of the 3.9 million Americans who received treatment for any kind of substance abuse problem in 2005, 2.5 million of them were treated for alcohol use.

“Improved outcomes are the mandate in all of healthcare, and Soberlink is at the forefront of this movement,” Keays said. “Soberlink is working hard to advance technology to improve outcomes in addiction treatment. These advances encourage transparency and flexibility and reinforce trust between the patient and treatment provider. FDA clearance is a significant milestone for our company and paves the way toward continued growth in the healthcare space.”

Soberlink is committed to changing the perception of alcohol use disorders by developing technology for addiction and recovery management. Since 2011, Soberlink has become the fastest growing recovery system on the market. The Soberlink System promotes accountability and connectivity with real-time BAC testing. Soberlink’s passionate pursuit of better recovery drove the company to develop SL1, the world’s first smartphone-enabled Breathalyzer. The company, based in Huntington Beach, Calif., remains at the forefront of innovation in the handheld, mobile breath category with the patented Soberlink Cellular, Soberlink Bluetooth and Sober Sky Web Portal.

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