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Home » Philips wins FDA clearance for AI MRI software SmartSpeed Precise

Philips wins FDA clearance for AI MRI software SmartSpeed Precise

July 2, 2025 By Danielle Kirsh

This is the logo of Philips.Philips (NYSE: PHG) has announced it received FDA 510(k) clearance for its deep-learning reconstruction tool, SmartSpeed Precise.

SmartSpeed Precise can scan up to three times faster and produce images up to 80% sharper than earlier methods. The technology is now cleared for clinical use on all Philips 1.5-tesla and 3-tesla MRI systems, including the existing installed base. The software integrates the company’s Compressed SENSE acceleration engine with two artificial intelligence models, one for denoising and another for sharpening and anti-ringing.

“This FDA clearance is a powerful validation of Philips’ leadership in AI-powered MRI innovation,” said Ioannis Panagiotelis, business leader of MR at Philips. “SmartSpeed Precise reflects our commitment to continuous innovation that addresses clinicians’ real-world pressures. 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.”

How the technology works

The company’s software uses its Compressed SENSE engine that undersamples raw data to shorten acquisition time. It then runs two AI models in sequence that strip out noise, restore edge definition, and remove ringing. The three steps run automatically once a technologist selects a preset, folding capture and reconstruction into a single workflow.

Philips said the technology offers a single-click workflow as a way to ease staff shortages and reduce patient backlogs. The company reports brain scans as short as seven seconds and breast MRI acquisition times cut by up to half.

“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 reduced by up to 50%, with image quality improving compared to previous Compressed SENSE protocols. That’s a game-changer.”

The software is available on new scanners and as an upgrade for current Philips 1.5T and 3.0T systems.

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), Imaging, Mammography, Regulatory/Compliance Tagged With: Philips

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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