Philips gets FDA clearance for Spectral CT Verida

Philips has received FDA 510(k) clearance for its Spectral CT Verida system, bringing its AI-powered spectral CT platform to the U.S.

Verida incorporates Spectral Precise Image, a third-generation Nano-panel Precise dual-layer detector, and an AI-based deep-learning reconstruction engine, according to Philips. Clinicians can customize image de-noising based on their preferences, the company said.

FDA records list the cleared device as the Spectral CT Verida Family under 510(k) K253649. The agency classified it as a Class II computed tomography X-ray system.

During acquisition, the scanner captures 1 CT dataset from higher-energy and lower-energy detected X-ray spectra. The FDA summary said those data can support material analysis, including attenuation, material density, and effective atomic number.

Reconstruction speed reaches 145 images per second, allowing exams to appear in less than 30 seconds, Philips said. The company said the premium configuration can support up to 270 exams per day during a 16-hour dual-shift workday.

Indications include diagnostic imaging in radiology, interventional radiology, and cardiology. The system is also indicated in oncology for treatment preparation and radiation therapy planning.

Clinical applications cover head, whole-body, cardiac, and vascular CT imaging in patients of all ages. The system is also intended for low-dose CT lung cancer screening when used within established screening protocols.

Spectral Precise Image is intended to reduce noise and improve image appearance in CT applications. FDA documentation states that pediatric use of the feature has not been clinically validated.

AI-based reconstruction outputs provide supplemental data for clinical interpretation and do not replace professional clinical judgment, according to the FDA summary.