The FDA has granted 510(k) premarket clearance to the Soberlink Breathalyzer for use in a medical setting. With this clearance, health care providers will be able 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.
“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 health care 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 enables individuals to test from nearly anywhere and at any time.
“Improved outcomes are the mandate in all of health care, and Soberlink is at the forefront of this movement,” says Brad Keays, founder and CEO of Soberlink. “[We are] 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.”
The FDA clearance is a significant milestone for our company and paves the way toward continued growth in the health care space,” he adds.