HyperVIEW X-Ray System Receives FDA Breakthrough Device Designation for Breast Cancer Imaging

The FDA has granted breakthrough device designation to the HyperVIEW X-ray system, which utilizes the K-Edge subtraction technique to allow for contrast-enhanced imaging for breast cancer diagnosis.1

The system also uses distributed charge laser-Compton X-rays, to produce 100-times higher–resolution imaging that is significantly safer than standard X-rays.

Findings from simulations published in Medical Physics showed that HyperVIEW may improve tumor detection by more than 3000% compared with existing contrast-enhanced mammography systems, which use traditional X-ray tubes.2,3 Additional data published in Frontiers in Physics demonstrated that HyperVIEW is one of the highest-resolution compact mono-energetic, x-ray imaging systems globally.1,4

“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,” Chris Barty, PhD, cofounder and chief technology officer of Lumitron, stated in a news release.1

Traditional mammographic screening approaches can miss as much as 20% of cancers with a positive predictive value of less than 5% in some instances.4 Contrast-enhanced mammography has been used in clinical practice for over 10 years and has demonstrated improved diagnostic power compared with traditional mammography. The approach displays a sensitivity to breast cancer that is comparable with 3-dimensional contrast-enhanced MRI and ultrasound combined with mammography. However, it has not been widely adopted across clinical practice partially due to the need for high-level clinicians, increased risk of adverse effects due to the use of iodine-based contrast agents, and the dose increase that results from 2 separate exposures.

The design of the laser-Compton X-ray system is based on compact distributed charge accelerator structures which enable micron-scale imaging of disease.4 The system also produces beams of very high energy electrons (VHEEs) capable of producing FLASH-relevant dose rates of approximately 10 Gy in less than 100 nanoseconds. The approach ensures that the X-rays follow the exact trajectory of the electrons from which the X-rays were originated, providing the opportunity for VHEE radiotherapy as well as image-guided VHEE FLASH radiotherapy.

Laser-Compton X-ray sources are also leveraged by K-edge subtraction imaging, a dual-energy X-ray technique that produces imaging via the accumulation of contrast agents, which are typically iodine based.3 The imaging modality utilizes the discontinuous change observed in the photoabsorption cross-section of the inner K-shell electrons at an energy that is unique to each element, known as the K-edge; the K-edge for iodine is 33.169 keV. By obtaining 2 images,1 with an energy level just above the K-edge and another with a level just below the K-edge, subtraction of the 2 images leaves enhancement at the point of contrast uptake.

K-edge subtraction has previously been used in cancer imaging due to leaky vasculature resulting from tumor angiogenesis. The K-edge subtraction method used by the HyperVIEW X-ray system employs a laser-Compton source that needs a single parametrization and energy tunning and utilizes continuous operation without a time delay to obtain the 2 separate images.

Additional findings from the Medical Physics article showed that the HyperVIEW approach produced a dose increase of less than 0.5% compared with the direct energy tuning method. Additionally, the laser-Compton source spectra produced an approximately 20% dose decrease compared with currently implemented clinical modalities. The laser-Compton source approach was also able to easily identify low-enhancing tumors that are often not detected with dual-energy contrast-enhanced mammography systems.

The breakthrough device designation for the HyperVIEW X-ray system was confirmed by the FDA on January 27, 2025, and announced by Lumitron Technologies on February 4, 2025.1

References

• FDA grants "Breakthrough Device" designation to Lumitron's HyperVIEW cancer detection X-Ray System. News release. Lumitron Technologies. February 4, 2025. Accessed February 21, 2025. https://www.lumitronxrays.com/single-post/fda-grants-breakthrough-device-designation-to-lumitron-s-hyperview-cancer-detection-x-ray-system
• Lumitron’s HyperVIEW™ is set to increase accuracy of mammography. News release. Lumitron Technologies. February 14, 2025. Accessed February 21, 2025. https://www.lumitronxrays.com/single-post/lumitron-s-hyperview-is-set-to-increase-accuracy-of-mammography
• Reutershan T, Nguyen CV, Effarah HH, Nelson EC, Chesnut KD, Barty CPJ. Scanning K-edge subtraction (SKES) imaging with laser-compton x-ray sources.Med Phys. Published online January 28, 2025. doi:10.1002/mp.17638
• Barty CPJ, Algots JM, Amador AJ, et al. Design, construction, and test of compact, distributed-charge, X-band accelerator systems that enable image-guided, VHEE FLASH radiotherapy. Front Phys. Published online December 10, 2024. doi:10.3389/fphy.2024.1472759