Philips Gains FDA Clearance for SmartSpeed Precise, Advancing AI-Driven MRI Scanning

Philips has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest deep learning MRI reconstruction software, SmartSpeed Precise, marking what the company describes as “a major milestone in the journey toward autonomous, personalized MRI.”

The new AI-powered software significantly improves MRI scan speed, image quality, and workflow efficiency. “This FDA clearance is a powerful validation of Philips’ leadership in AI-powered MRI innovation,” said Ioannis Panagiotelis, PhD, business leader MR at Philips. “SmartSpeed Precise reflects our commitment to continuous innovation that addresses clinicians' real-world pressures.”

SmartSpeed Precise uses artificial intelligence to accelerate image acquisition, enhance resolution, and simplify operation through one-click workflows. According to Philips, the software enables technologists to complete many scans up to three times faster than before. Routine brain scans can now be performed in as little as 10 seconds, and breast MRI scan times can be cut by as much as 50%.

The image quality also benefits from the software’s deep learning-based denoising algorithms, which improve image sharpness by up to 80%. Additionally, SmartSpeed Precise features protocol optimization tools that standardize image quality across diverse patient body types and varying levels of technologist experience.

“By integrating dual AI with our proven Compressed SENSE engine, we are enabling faster, sharper, and smarter MR scans—making high-quality imaging more accessible and efficient than ever before,” said Panagiotelis.

Clinicians are already seeing tangible results. “SmartSpeed Precise helps us do what was previously thought impossible—deliver sharper, faster MRI with less effort,” said Julian Luetkens, MD, professor of radiology at University Hospital Bonn in Germany. “In breast MRI, we saw acquisition times reduced by up to 50%, with image quality improving compared to previous Compressed SENSE protocols. That’s a game-changer.”

SmartSpeed Precise is now available for all new Philips MRI scanners and can be installed across existing 1.5T and 3.0T MR systems. The upgrade is software-only and requires no additional hardware investment.

With FDA clearance secured, Philips positions itself at the forefront of AI-enhanced medical imaging, promising a future where MRI is not only faster and clearer but also more accessible and user-friendly.