AT1 FY21 - General Discussion + FA, page-2387

They have FDA clearance, rather than FDA approval I believe.

This is what Bing says when I asked what the difference between FDA clearance and FDA approval was:

"FDA approval and FDA clearance are two different regulatory processes that the FDA uses to evaluate medical devices and drugs. FDA approval is a higher standard because the safety and effectiveness of the specific product has been tested1. The FDA approves drugs, while it clears medical devices2. FDA clearance is a lower standard, and in many cases, the product is cleared because it is similar to an existing product rather than that it has passed rigorous independent safety trials."

this company management track records are extremely bad!