Yes, but not at the expense of burning through cash.
Optomed is of course aiming for a streamlined regulatory process in the US—after all, Lumo is an evolved model from Aurora—but they shouldn’t rush into any multi-million euro validation studies. Not until cash flow has been proven to have turned positive, with enough of it left over for R&D in the form of Lumo’s regulatory application. I wouldn’t accept the risk of sinking cash into Lumo’s FDA clearance while cutting corners to save costs, only to end up with a ‘rejected’ outcome.
Edit: And Lumo does have FDA clearance. Just not for the AI analysis.