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# Lumitron Get Breakthrough Status for New X-Ray
- URL: https://www.fdaweb.com/lumitron-get-breakthrough-status-for-new-x-ray/
- Published: 2025-02-04T12:00:00.000Z
- Updated: 2026-09-14T14:52:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158601

FDA has granted Lumitron Technologies a breakthrough device designation for its HyperVIEW X-Ray system, which uses the “K-Edge subtraction technique” to enable contrast-enhanced imaging for diagnosing breast cancer. “This technology utilizes Lumitron’s proprietary distributed charge laser-Compton technology to provide imaging that is both 100 times higher resolution and significantly safer than standard X-Rays,” the company says. “Being listed in the FDA’s Breakthrough Device Program will enable Lumitron’s HyperVIEW X-Ray system to accelerate through the approval process and hopefully bring this revolutionary technology to the clinic faster,” it says.