Philips' SmartSpeed Precise AI Software Gains FDA 510(k) Clearance, Enhancing MRI Speed and Accuracy

Philips has received FDA 510(k) clearance for its latest AI-powered MRI software, Smart Speed Precise, a significant step toward more autonomous and personalized MRI. This new deep learning reconstruction software is the first in the industry to integrate a dual AI solution, enabling scans up to three times faster and producing images up to 80% sharper, all with a single click.

First introduced at the 2025 European Congress of Radiology (ECR 2025), SmartSpeed Precise is now approved for clinical use across Philips’ full range of 1.5T and 3.0T MRI systems, including its large installed base. This broad compatibility makes it one of the most scalable and impactful MRI innovations available today.

SmartSpeed Precise combines three powerful technologies into one seamless solution, which includes:

• Compressed SENSE, Philips’ gold-standard acceleration engine;
• An AI-powered denoising engine, enhancing image clarity by reducing noise; and
• A second AI engine for image sharpening and anti-ringing, ensuring exceptional definition and diagnostic quality.

“This FDA clearance strongly affirms Philips’ leadership in AI-powered MRI,” said Ioannis Panagiotelis, PhD, Business Leader MR at Philips. “SmartSpeed Precise demonstrates our commitment to solving real-world clinical challenges. By combining dual AI technology with our proven Compressed SENSE engine, we’re delivering faster, clearer, and more intelligent MRI scans, improving both efficiency and access to high-quality imaging.”

As healthcare systems around the world struggle with rising demand for MRI scans, staffing shortages, and growing patient wait times, Philips new solution is aimed at relieving pressure on overburdened radiology departments. The company’s newly FDA-cleared software, SmartSpeed Precise, is designed to improve workflow efficiency, speed up scan times, and enhance diagnostic accuracy without compromising image quality.

The Philips Future Health Index 2025 Global Report underscores the urgency of the situation, highlighting that healthcare professionals increasingly view artificial intelligence as a key tool, not only to reduce administrative workload but also to improve disease diagnosis, lower hospital readmissions, and enhance overall patient outcomes.

SmartSpeed Precise is fully integrated into Philips' MRI systems, allowing radiology teams to operate with greater speed and precision. The dual AI-powered software enables faster scans and sharper images, streamlining daily operations and making high-quality imaging more accessible across clinical environments.

“SmartSpeed Precise helps us do what was previously thought impossible, deliver sharper, faster MRI with less effort,” said Dr. Julian Luetkens, Professor of Radiology at University Hospital Bonn. “In breast MRI, we saw acquisition times cut by up to 50%, with image quality actually improving compared to previous Compressed SENSE protocols. That’s a game-changer.”