PRESS RELEASE: The genuine LifeVac has become the first and only airway clearance device in the world to be authorised by the FDA for use as a second-line treatment in choking, when first aid fails.

After over 5500 documented and successful saves worldwide, the genuine LifeVac has managed to achieve an important milestone and has become the only airway clearance device to be authorised for advertising and sale by the FDA in the USA under a new classification, specifically developed for this leading device. Despite being told by detractors that this was not possible and that there was “insufficient evidence”, LifeVac has achieved the impossible.

The LifeVac has been extensively reviewed clinically, for evidence, risk and safety by the TGA in Australia during a 2-year long post market review, and listed as a Class 1 (low-risk) medical device (ARTG#285082). Under Australian law and legislation, the LifeVac device does not require any further “endorsement” or “approval” from any other body or organisation to be used in Australia. This new official authorisation status of the LifeVac by the FDA is set to change the management of choking, by adding a tool that can (and has) saved lives when first aid fails on thousands of occasions. https://www.accessdata.fda.gov/cdrh_docs/pdf25/DEN250012.pdf

“In Australia, we have had critics (including some councils, government and private organisations), claim that their barrier to their adoption of the LifeVac has been the FDA. This excuse can no longer be used, with the FDA authorisation of LifeVac through a thoroughly evidenced de novo application.“ – Simon Gould – Owner of LifeVac Australia.

Worldwide, there is only one airway clearance device authorised by the FDA, the LifeVac. This should have important implications in Australia, where the TGA has been unwilling to regulate dangerous counterfeit LifeVac devices, but now has advice and a determination from the FDA, as to the safety, evidence and efficacy of the genuine LifeVac as representing a class of its own.

“Our mission has always been focused on saving lives. There have been speculators and conspiracy theorists who have cast doubt on the LifeVac and misled others about its safety, efficacy, evidence and ”legal” use in Australia. Authorisation by the FDA has exonerated LifeVac and should encourage the consideration of facts when deciding on a life-saving device rather than unqualified opinions” – Simon Gould – Owner LifeVac Australia.

LifeVac is already in pre-schools, daycare centers, schools, residential aged care facilities, disability services, businesses and homes; and has been rolled out by councils and organisations across Australia and looks forward to saving more lives in the future.