Spectrum Dynamics Medical Receives FDA 510(k) Clearance for Veritas.AI

Spectrum Dynamics Medical, a global leader in digital nuclear medicine imaging solutions, today announced that it has received FDA 510(k) clearance for Veritas.AI Noise Reduction, its advanced artificial intelligence platform designed to significantly enhance image quality, diagnostic confidence, and operational efficiency on the VERITON-CT digital SPECT/CT system.

Veritas.AI represents a major advancement in molecular imaging, leveraging a deep learning convolutional neural network (CNN) to intelligently reduce image noise while preserving the highest spatial resolution and quantitative accuracy. The technology is clinically validated across multiple applications and tracers, including bone imaging, Lu-177 theranostics, and I-123 MIBG, addressing some of the most demanding imaging scenarios in nuclear medicine.

Veritas.AI decreases the scanning times by up to 50% and improves image quality in low-count and high-noise conditions. Veritas.AI enables clinicians to maintain diagnostic accuracy while improving patient comfort and increasing department throughput. Unlike conventional denoising techniques, Veritas.AI performs seamlessly across a wide range of imaging conditions, from routine diagnostic scans to delayed post-therapy imaging.

The Veritas.AI Noise Reduction suite includes dedicated applications optimized for specific clinical needs:

• Bone-IQ.AI, enabling up to 50% reduction in scan time for whole-body bone imaging while maintaining image quality and enabling throughput of 2–3 patients per hour.
• Thera-IQ.AI, purpose-built for Lu-177 theranostics, improving post-treatment image quantitative accuracy, and harmonizing noise across time points, which may enhance the accuracy of dosimetry and improve lesion detectability.
• MIBG-IQ.AI, designed for I-123 MIBG imaging, enabling up to 50% reduction in scan time, delivering safer, faster, and more comfortable exams for children.

When combined with the VERITON-CT’s 360 CZT digital detector architecture, wide-bore design, and quantitation-ready workflows, Veritas.AI further strengthens Spectrum Dynamics’ leadership in digital SPECT/CT imaging—supporting routine clinical practice, advanced theranostics, and clinical research.

“Receiving FDA clearance for Veritas.AI is a significant milestone for Spectrum Dynamics and for the nuclear medicine community,” said Tomer Gabay, chief executive officer of Spectrum Dynamics Medical. “As innovation leaders, we are incredibly excited to bring this powerful AI innovation solution to our customers. Veritas.AI strengthens our commitment to precision imaging by delivering clearer images, greater clinical confidence, and more efficient workflows, while helping hospitals prepare for the rapid growth of theranostics and quantitative SPECT/CT.”

This FDA clearance underscores Spectrum Dynamics’ continued investment in AI-driven innovation, setting a new standard for clarity, confidence, and clinical value in nuclear medicine.