Certification strengthens Koning’s global regulatory foundation as two new Vera Breast CT systems expand patient access in key U.S. markets

NORCROSS, Ga., Aug. 4, 2026 /PRNewswire/ — Koning Health, global leader in advanced breast imaging technology, today announced that it has achieved certification under the Medical Device Single Audit Program, or MDSAP, while continuing to expand its U.S. installed base with new Koning Vera Breast CT systems in the greater Seattle area and Richmond, Virginia.

MDSAP is an internationally recognized regulatory audit program that allows a medical device manufacturer’s quality management system to be evaluated through a single, comprehensive audit against the requirements of multiple participating regulatory authorities, including those in the United States, Canada, and Australia. The audit examines the systems governing product design, manufacturing, risk management, supplier oversight, complaint handling, and post-market monitoring.

For Koning, this certification provides independent validation that the company’s quality and regulatory infrastructure meets rigorous international standards and is a step forward in Koning’s global commercialization strategy, particularly following the company’s regulatory submissions to Health Canada and Australia’s Therapeutic Goods Administration (TGA).

By achieving MDSAP certification, Koning has completed a core quality-system requirement supporting registration in these markets and has materially advanced Vera Breast CT toward commercial availability in Canada and Australia.

“Achieving MDSAP certification is a major milestone for Koning and an important validation of the quality systems supporting our technology,” said David Georges, President of Koning. “It strengthens the regulatory foundation for our expansion into several of the world’s most important medical device markets while demonstrating our continued commitment to quality, patient safety and operational excellence.”

The certification comes as Koning continues to grow its commercial presence in the United States. The installations at Vital View in Seattle and Executive Health Group in Richmond, VA reflect increasing demand for advanced breast imaging solutions among organizations focused on proactive, precision-based healthcare.

The Koning Vera Breast CT system produces true isotropic 3D images of the breast in less than 10 seconds per side. The system images patients while they are lying comfortably in a prone position and does not require painful breast compression associated with conventional mammography.

“Each new installation represents more than commercial growth. It represents a new community of patients gaining access to a more comfortable and advanced breast imaging experience,” said Georges. “Vital View and Executive Health Group share our commitment to improving how breast imaging is delivered, and we are proud to welcome them to the growing network of Koning Vera providers.”

“At Executive Health Group, our leadership in longevity and preventive medicine is grounded in identifying health risks earlier and helping patients make more informed decisions about their long-term health,” said Dr. Randy Baggesen, Founder of Executive Health Group. “The addition of Koning Vera Breast CT reflects that commitment. It brings an advanced, patient-centered approach to breast imaging into our platform and strengthens our ability to support earlier detection and better health outcomes.”

Kelly Kaye, Founder of Vital View in Washington, says, “We are incredibly proud to be the first in WA state to offer imaging choices for women and providers, giving them a Vital View into breast health.”

Together, the MDSAP certification and the two new installations demonstrate Koning Health’s continued progress toward broader commercialization, increased international market access and expanded availability of advanced breast imaging technology.

About Koning Health
Koning Health is a global health technology company dedicated to advancing breast imaging through its patented Koning Vera Breast CT system. The Koning Vera Breast CT is designed to provide true 3D images of the breast for diagnostic evaluation. Koning’s mission is to enhance the way clinicians visualize and assess breast tissue using advanced computed tomography technology while providing a more comfortable breast imaging experience to patients. For more information, please visit www.koninghealth.com or contact info@koningcorporation.com.

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SOURCE KONING CORPORATION