FDA grants 'Breakthrough Device' designation to Lumitron’s HyperVIEWTM cancer detection X-Ray System

Breakthrough status announced on World Cancer Day (Feb. 4)

IRVINE, CA, UNITED STATES, February 4, 2025 /EINPresswire.com/ -- The U.S. Food & Drug Administration (FDA) has granted Lumitron Technologies, Inc. the designation of “Breakthrough Device” for its HyperVIEWTM X-Ray system utilizing the K-Edge subtraction technique to enable contrast-enhanced imaging for diagnosis of 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.

“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,” said Dr. Chris Barty, co-founder and Chief Technology Officer of Lumitron.

Peer-reviewed studies published by Frontiers In Physics show that HyperVIEW is the world’s highest-resolution, compact mono-energetic, x-ray imaging system. It has the promise of forever changing the way breast cancer is detected.

The breakthrough designation was confirmed by the FDA on January 27th and announced by Lumitron Technologies, Inc. on February 4th, World Cancer Day.

Click here to see an animation of how Lumitron envisions its HyperVIEW X-Ray system can revolutionize breast cancer detection and treatment as part of an image-guided Very High Energy Electron FLASH radiotherapy system.

https://www.lumitronxrays.com/animation


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Brian Lochrie
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HyperVIEW Animation