FDA gives premarket clearance for connected breathalyzer

The Soberlink system--Courtesy of Soberlink


The Soberlink cellular device--Courtesy of Soberlink

Soberlink has earned 501(k) premarket clearance from the FDA for its Soberlink Breathalyzer. The clearance means that healthcare providers can use the device to measure alcohol in breath to aid in monitoring the alcohol consumption of those who have alcohol use disorders.


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The Soberlink system includes a cellular device that connects with the Sober Sky Web Portal. A facial recognition function on the cellular device eliminates risk of falsifying tests, and the web-based portal allows users to easily share blood alcohol levels with their care providers. 

Using Soberlink’s breathalyzer along with the Sober Sky Web Portal offers a way for people to discreetly share blood alcohol content levels with their treatment providers. The system allows for remote clinical monitoring that removes the hassle of traditional urinalysis done in a lab.

Patients will experience better long-term outcomes the longer they use the consistent monitoring system.

Through its partnership with Verizon Wireless, Soberlink offers a cellular device that is connected to the Sober Sky Web Portal. Users can test themselves anywhere.

“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,” said 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.”

According to Soberlink, the system has been the fasted growing recovery system on the market since 2011.

“Soberlink is working hard to advance technology to improve outcomes in addiction treatment,” said Brad Keays, the founder and CEO of Soberlink. “These advances encourage transparency and flexibility and reinforce trust between the patient and treatment provider.”

- here's the announcement

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