Empower Clinics Inc said it was temporarily pausing the sale of its Kai Care At-Home Covid 19 and Influenza A/B Test Kits (Kai Care Test) but they will still be available for sale in the US while the firm responds to a review requested by Health Canada.
The review centers around assigning the most appropriate medical device class for the medical test.
READ: Empower says its Kai Medical Lab launches a revenue generating program targeting over 500 Texas schools
The Kai Care Test was authorized for sale in Canada under a Device Class I designation on March 1 this year, the integrated healthcare company said in a statement.
But a class IV authorization may be required going forward, it added.
"The company is temporarily ceasing distribution in Canada until the Health Canada review can be completed, and a determination is made on which Medical Device Class authorization is required," it told investors in a brief statement.
"During this time, Kai Care tests will still be available unimpeded for sale and distribution in the U.S. market. The product remains fully authorized in the U.S. market and continues to be safely used by thousands. The company is working diligently with Health Canada to resolve the matter in an expedient manner," it added.
Empower provides body and mind wellness for patients through its clinics, with digital and telemedicine care, and world-class medical diagnostics laboratories.
Contact the author at giles@proactiveinvestors.com