Difficult to answer the 'why', though I suspect arrogance, stubbornness, and unwarranted hubris have something to do with it.
Another FDA clearance would be nice for a short run, but with a CEO who blows a literal golden opportunity with CVS and loses the rights to use the CE mark and costs himself $500K plus in revenue, don't expect any capitalization on more FDA approvals, I don't care if they clear it for curing cancer.....