NEW YORK – Diagnostica Stago said Friday it received US Department of Defense Health Agency cybersecurity clearance that will let the department's military treatment facilities to buy the company's Max Generation analyzers and middleware and connect them to the DHA network.
The France-based firm said the Authorization to Operate (ATO) clearance followed extensive review of applications for its STA R Max and Sta Compact Max analyzers as well as the firm's STA Coag Expert software. The analyzers are used to aid in the diagnosis of coagulation abnormalities or monitor anticoagulant therapy.
The firm said its cybersecurity, software development, and product management teams worked with DHA Cybersecurity Logistics over the last year to review the applications incorporated with the instruments and software.
"Receiving the ATO demonstrates to customers that we are committed in providing the highest quality hemostasis products with software applications that pass some of the most stringent security requirements," Stago CEO Philippe Barroux said in a statement. "We are proud to deliver our products and services to military personnel throughout the US and beyond."
The firm also secured US Food and Drug Administration 510(k) clearance in June for the newest versions of its STA R Max and STA Compact analyzers. It plans to launch the fully automated instruments in the US market at the 2023 American Association for Clinical Chemistry Scientific Meeting July 25-28 in Anaheim, California.