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Philips Receives FDA Clearance for AI-Powered MRI Software That Accelerates Scans by 3x

16 days ago2 min read

Key Insights

  • Philips has received FDA 510(k) clearance for SmartSpeed Precise, an AI-powered MRI reconstruction tool that can scan up to three times faster while producing images up to 80% sharper than earlier methods.

  • The software integrates Philips' Compressed SENSE acceleration engine with dual AI models for denoising and image sharpening, offering a single-click workflow to address staff shortages and patient backlogs.

  • Clinical testing at University Hospital Bonn demonstrated breast MRI acquisition times reduced by up to 50% with improved image quality compared to previous protocols.

Philips has received FDA 510(k) clearance for SmartSpeed Precise, a deep-learning reconstruction tool that promises to transform MRI imaging by delivering significantly faster scan times while maintaining superior image quality. The technology can scan up to three times faster and produce images up to 80% sharper than earlier methods.

Advanced AI Integration for Enhanced Performance

SmartSpeed Precise integrates Philips' proven Compressed SENSE acceleration engine with two artificial intelligence models working in sequence. The first AI model focuses on denoising, while the second handles sharpening and anti-ringing effects. This dual AI approach runs automatically once a technologist selects a preset, creating a seamless single-click workflow that combines capture and reconstruction into one streamlined process.
"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."

Clinical Impact and Real-World Performance

The technology addresses critical healthcare challenges including staff shortages and patient backlogs through its simplified workflow. Clinical testing has demonstrated remarkable performance improvements, with brain scans completed in as short as seven seconds and breast MRI acquisition times reduced by up to half.
Dr. Julian Luetkens, professor of radiology at University Hospital Bonn, reported significant clinical benefits from the technology. "SmartSpeed Precise helps us do what was previously thought impossible—deliver sharper, faster MRI with less effort," said Dr. Luetkens. "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."

Technical Implementation and Availability

The software operates by using Philips' Compressed SENSE engine to undersample raw data, thereby shortening acquisition time. The system then applies two AI models sequentially to strip out noise, restore edge definition, and remove ringing artifacts. This three-step process runs automatically, requiring minimal technologist intervention.
SmartSpeed Precise is now cleared for clinical use on all Philips 1.5-tesla and 3-tesla MRI systems. The technology is available both on new scanner installations and as an upgrade option for existing Philips MRI systems in the current installed base, providing flexibility for healthcare facilities looking to enhance their imaging capabilities without requiring complete system replacement.
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