FDA Clears Philips’ SmartSpeed Precise Dual AI Software for MRI

Philips has been awarded U.S. Food and Drug Administration (FDA) 510(k) clearance for SmartSpeed Precise MR’s latest deep learning reconstruction software.

The company said this is a major milestone toward autonomous, personalized MRI. SmartSpeed Precise is the industry’s first integrated dual artificial intelligence (AI) solution, providing up to three times faster scanning and up to 80% sharper images, according to the company.

The software is now cleared across Philips’ portfolio of 1.5T and 3T MRIs, including its installed base. It combines three tech into one solution, which includes the Compressed SENSE acceleration engine, an AI-powered denoising engine, and a second AI engine for image sharpening and anti-ringing.

The integrated of SmartSpeed Precise lets radiology teams harness AI in a single solution that simplifies daily operations, accelerates scans, and consistently provides sharp, high-quality images. A one-click workflow promotes consistent imaging, with easy protocol optimization ensuring reliable results—even in challenging cases like pediatric, elderly, or uncooperative patients.

According to Philips, diagnostic scan times using the software can be reduced to levels not seen before, including an under ten-second brain scan.

“This FDA clearance is a powerful validation of Philips’ leadership in AI-powered MRI innovation,” said Ioannis Panagiotelis, Ph.D., Business Leader 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.”

Last week, the company expanded its longstanding partnership with Medtronic with a new multi-year agreement, which will focus on broadening access to advanced patient monitoring and high-quality care.