{"url":"https://newsforagent.com/news/2026-10-20/koning-vera-breast-ct-health-canada-licence","markdown_url":"https://newsforagent.com/news/2026-10-20/koning-vera-breast-ct-health-canada-licence.md","title":"Koning Vera Breast CT Wins Health Canada Licence","headline":"Koning Health's Vera Breast CT System Receives Health Canada Medical Device Licence","description":"Koning Health's Vera Breast CT system has received a Health Canada Medical Device License, opening the door to commercial use in Canadian clinical settings.","section":"Regulation & Approvals","published_at":"2026-10-20T19:18:21+00:00","modified_at":"2026-10-20T19:18:21+00:00","author":"News Desk","key_takeaways":["Koning Health's Koning Vera Breast CT system received a Medical Device License from Health Canada on October 20, 2026.","The system uses cone beam computed tomography to produce 3D breast images without breast compression.","Patient scan availability in Canada will depend on individual imaging centers' implementation timelines."],"companies":[{"name":"Koning","is_primary":true,"profile_url":"https://akta.pro/company-profiles/0000xw3/koning","website":"https://www.koninghealth.com"},{"name":"Health Canada","is_primary":false,"profile_url":"https://akta.pro/company-profiles/0006fzo/health-canada","website":"https://dhpp.hpfb-dgpsa.ca"}],"source":{"publisher":"PR Newswire","title":"Koning Vera Breast CT Receives Licensure from Health Canada for Breast Imaging in Canada","url":"https://www.prnewswire.com/news-releases/koning-vera-breast-ct-receives-licensure-from-health-canada-for-breast-imaging-in-canada-302914525.html"},"other_sources":[],"tags":["Regulation & Approvals","Koning","Health Canada"],"body_markdown":"[Koning](https://akta.pro/company-profiles/0000xw3/koning) Health announced on October 20, 2026 that its Koning Vera Breast CT system received a Medical Device License from [Health Canada](https://akta.pro/company-profiles/0006fzo/health-canada), allowing commercial use in Canadian clinical settings. The Norcross, Georgia-based company said the licence covers its dedicated breast computed tomography technology, which produces three-dimensional images without breast compression. [PR Newswire](https://www.prnewswire.com/news-releases/koning-vera-breast-ct-receives-licensure-from-health-canada-for-breast-imaging-in-canada-302914525.html) carried the announcement.\n\n## What the Health Canada Licence Covers\n\nThe Medical Device License authorizes the commercial introduction of the Koning Vera Breast CT system into Canadian clinical settings, according to the company. Koning said the licensure establishes a pathway to expand clinical access across the country. Patient scan availability will be determined by individual participating imaging centers and hospital systems based on their own implementation timelines, the company said.\n\nThe system, also known as KBCT, uses cone beam computed tomography to generate volumetric images of breast tissue, letting clinicians examine the breast from multiple angles without compressing it during image acquisition. Koning said the design addresses two priorities: detailed anatomical information for clinical evaluation and a changed physical experience of the examination.\n\n\"Women want to know that advances in breast imaging will make a difference in their experience of care,\" said David Georges, President of Koning. \"Our Vera Scan brings together detailed three-dimensional imaging and an examination that does not require breast compression. With Health Canada licensure, we can take the next steps toward bringing that technology to Canadian providers and their patients.\"\n\nThe authorization follows Koning's recent registration in Australia, the company said.\n\n## Koning's Funding and Global Footprint\n\nKoning is a private medical device company founded in 2002 and headquartered in Norcross, according to [company records](https://akta.pro/company-data) on akta.pro. The same records list total funding of $18.7 million at Series C stage, with the last round dated May 22, 2025, and a headcount range of 11-50. The records also show more than 120 patents globally in breast CT technology and a milestone of 150,000 scans completed globally, announced in March 2024.\n\n## Earlier Steps Toward Canadian Approval\n\nKoning Health announced in August 2026 that it had achieved MDSAP certification, an internationally recognized medical device quality management audit program, which it said advances its regulatory submissions in Canada and Australia, PR Newswire reported. In September 2026, the company announced that the Koning Breast CT System was added to the Australian Register of Therapeutic Goods, enabling commercial supply, with the TGA approving the device on September 8, 2026, and Brisbane Radiology as the first Australian provider to purchase it, PR Newswire reported. In October 2026, Koning announced an agreement with HealthTrust Performance Group making it an approved vendor and creating a streamlined pathway for member organizations to access the Koning Vera Breast CT, an agreement that began the previous month, PR Newswire reported.\n\n## What Comes Next for Canadian Providers\n\nCanadian healthcare providers interested in the Koning Vera Breast CT can contact Koning Health to discuss the technology and opportunities for implementation, the company said. Koning's own [announcement](https://www.koninghealth.com) directs providers to the company for implementation discussions.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}