Canon gains FDA clearance for new ultrasound processing algorithms ahead of RSNA

AI-assisted third harmonic imaging

The most significant advancement, according to Skyba, is a new FDA-cleared evolution in harmonic imaging. He described the technology as an expansion of the long-established second harmonic approach. The new technology is designed to extract even higher-order harmonic components to improve spatial resolution and reduce noise from the third harmonic signal. These are faint and difficult to isolate, but he said Canon is using AI to enhance the detection process.

“What the engineers have done is very clever. They trained AI to go out and search for third harmonic components and bring in the real signal and minimize the noise that comes back,” Skyba said. “This is the first time that we know of that artificial intelligence is being used in the imaging component of ultrasound, and not say just in the workflow component.”

The reduction in reverberation and noise is especially helpful for hypoechoic, or fluid-filled structures, such as the gallbladder, bile ducts or cystic masses. “You can activate third harmonic imaging and it clears out the reverberation and gives you the real information from within those structures," Skyba said.

Enhanced microvascular ultrasound imaging

Canon also has extended its proprietary Superb Microvascular Imaging (SMI) technology. Originally designed for detecting low-velocity flow, SMI currently improves both the sensitivity of slow-flow detection, and expands its applicability to higher-flow vessels. Canon’s newest release gets back to improving the detail in even smaller vascular structures.

“In the prior generation, we had improved the SMI technology and we've actually applied a lot of that algorithm to high flows as well,” he said, noting that now with the latest improvement called SMI Angio mode, the system can detect “even a lower level of the microvasculature” with improved spatial sharpness and anatomic separation.

Auto tune shear wave elastography improves image quality

The new software package also includes a major update to shear wave elastography, aimed at improving image consistency across diverse tissue types.

"The shear waves are moving at wildly different speeds in soft structures versus stiff structures. So, it's difficult sometimes to optimize the unit to do its best in quantifying those elastography signals. Sonographers can often struggle. So, Canon created something called auto tune shear wave,” Skyba explained.

The system rapidly evaluates whether tissue is soft, such as liver, or extremely stiff, such as musculoskeletal tendons, and adjusts its transmit and receive sequences accordingly. It sends out sensing pulses very quickly to assess if the sonographer is looking at something that's very soft, or structures that are very stiff.

"It give you a better quantitative result, so it's going to make things a lot easier and a lot more accurate in all of those types of studies, and hopefully improve the accuracy for radiologists," Skyba said

Canon Medical will demonstrate all three technologies during live scanning sessions in its booth at RSNA 2025.