Soberlink secures 510(k) premarket clearance from FDA for breathalyser

18 July 2016 (Last Updated July 18th, 2016 18:30)

Soberlink has secured 510(k) premarket clearance from the US Food and Drug Administration (FDA) for medical use of Breathalyser by healthcare providers to remotely measure alcohol levels in human breath.

Soberlink has secured 510(k) premarket clearance from the US Food and Drug Administration (FDA) for medical use of its breathalyser by healthcare providers to remotely measure alcohol levels in human breath.

The device aids detection and controlling of alcohol consumption in those sufferring from alcohol use disorders.

Treatment Research Institute founder and chairman of the board of directors Tom McLellan said: “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.

"It is about time that we have the same kind of technology to provide personalised, continuing care for alcohol use disorders."

“It is about time that we have the same kind of technology to provide personalised, continuing care for alcohol use disorders.”

Soberlink and Sober Sky Web Portal serve as an accountability tool that enables recovering individuals to conveniently and discreetly share blood alcohol content (BAC) results with their treatment providers and recovery circle from anywhere.
in the world.

To develop a protocol for using the Soberlink System in clinical monitoring of alcohol use disorders, Soberlink has worked for over five years with top treatment facilities and addiction experts.

Urinalysis testing has been a regular standard of care for alcohol monitoring. Due to the flexibility of the Soberlink System and partnership with Verizon Wireless, testing is now not confined to a lab environment, but individuals can take test from anywhere and at any time.