Bentley443 is right on the money. This is a strong microbiology play, and the new principal shareholders will get FDA and European approval for their patented processes, and every risk manager in the Western world will have to purchase one for their hospital, not to mention the one time use disposable specimen trays. And that's only part of this company's intellectual property.
I am assuming FDA approval, for U.S. sales. In a discussion with a member of the new management team at the annual meeting, I got the feeling the FDA route was a road they had traveled before with their previous medical company (very impressive management CV). Remember, this is not a pharmaceutical approval where a patient risks ingesting something inappropriate. This is a machine that detects bugs. Not a risk for the patient.