Founded by Dr. Ruola Ning in 2002 under an exclusive University of Rochester license, Koning Health develops and manufactures the Koning Vera, a dedicated breast CT system that produces true three-dimensional images without breast compression. Its U.S.-made device scans each breast in less than 10 seconds and supports diagnostic imaging and 3D-guided biopsy, with FDA PMA approval and more than 150,000 scans completed worldwide.
CE Mark
ISO 13485
FDA PMA Approval for Koning Breast CT (CBCT1000)
Registration
FDA Diagnostic Use Clearance
Compliance program
FDACLEARANCE
Quality certification
UE LifeSciences IncFounded in 2009, UE LifeSciences develops hand-held medical devices and digital tools that make early cancer detection more accessible, starting with its FDA-cleared iBreastExam for quick, painless, radiation-free breast-lump screening. Its Philadelphia-rooted, globally distributed team designs systems for community health workers and has supplied more than 2 million breast exams across 10 markets, with newer tools extending screening to cervical and oral cancer. The company also established an ISO 13485- and WHO-GMP-certified manufacturing facility in India as it expanded internationally.WEST CHESTER, PA
Xcision Medical Systems, LLCColumbia-based Xcision Medical Systems develops stereotactic radiotherapy technology focused specifically on breast cancer, led by its GammaPod system for early-stage disease. Developed from a patent licensed from the University of Maryland School of Medicine, GammaPod uses focused, noninvasive radiation and is designed to shorten treatment to as few as five days. The system has received FDA 510(k) clearance and carries the CE Mark in Europe.COLUMBIA, MD
First Source IncSince 1999, Rochester’s First Source Inc. has manufactured and fabricated X-ray imaging systems, digital detectors, and image-acquisition software in-house. Its portable equipment is built for settings ranging from hospitals and home health care to veterinary fieldwork, with the company also providing USA-based technical support, repair, and refurbishment. First Source’s hands-on manufacturing model and specialized veterinary and mobile-imaging work distinguish it from a standard equipment reseller.ROCHESTER, NY