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Koning Health Secures MDSAP Certification and Expands U.S. Footprint

Koning Health has secured Medical Device Single Audit Program (MDSAP) certification, a critical regulatory milestone that accelerates the company’s push into Canadian and Australian markets. Simultaneously, the Georgia-based imaging firm is scaling its domestic presence with new installations of its Vera Breast CT systems in Seattle and Richmond.

Koning Health Secures MDSAP Certification and Expands U.S. Footprint
Photo: Bio & News

The MDSAP certification validates the company's quality management infrastructure against the rigorous standards of multiple regulatory authorities. By consolidating audits for the U.S., Canada, and Australia into a single process, the company has bypassed significant regulatory hurdles, clearing a path for the international commercialization of its 3D imaging technology.

Alongside this regulatory progress, Koning is expanding its clinical reach through new installations at Vital View in Seattle and the Executive Health Group in Richmond, Virginia. These facilities are replacing traditional, compression-heavy mammography with the Vera Breast CT, which captures isotropic 3D images in under 10 seconds. According to company president David Georges, the expansion reflects a shift toward precision-based preventive care, with partners like Dr. Randy Baggesen of Executive Health Group emphasizing the system's role in earlier health risk detection.

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