Dive Brief:

• Canon Medical Systems USA has received 510(k) clearance for a technology to improve the reconstruction of CT images, the company said Monday.

• The FDA clearance covers an AI technology Canon designed to separate signal from noise in CT imaging data, improving image quality while reducing the radiation dose.

• Canon created the AI for use with products in its Aquilion line of CT systems, which the company singled out as a growth driver in its second quarter financial results.

Dive Insight:

CT scans, like all X-ray imaging, entail a tradeoff between image quality and radiation dose. Rising use of CT scans, which expose patients to far more radiation than X-rays, has intensified the focus on the risks of the imaging technique, particularly in the pediatric population. FDA and groups representing healthcare professional want to use the lowest possible dose but their ability to expose patients to less radiation is limited by the tradeoff in image quality.

Canon expects its Advanced Intelligent Clear-IQ Engine can change the terms of the tradeoff. In a statement published by Canon, Frédéric Ricolfi, of the Centre Hospitalier Universitaire in France, said the addition of AICE to a CT system increased the signal-to-noise ratio by 25% while reducing the dose for body imaging and cardiac examinations by 20% and 40%, respectively. 

The claimed improvements stem from the use of AI to identify noise in the image data. Canon claims that pixel level analysis and associated deep learning system lets clinicians capture very high resolution images without increasing the dose. 

If Canon can persuade clinicians to buy into the concept, AICE could provide a boost for an important product line. AICE works with the Precision and Genesis editions of its Aquilion line of CT systems. Canon said Aquilion Genesis and its sibling Aquilion Start were key drivers of overseas sales at its medical unit in the second quarter.

Outside of its home territory of Japan, Canon grew sales of medical systems by 14.2% in the quarter. The ex-Japan performance was driven by a 21.7% jump in sales in the Americas. Canon attributed the growth to increasing replacement demand for equipment in the U.S. 

Despite the growth, Canon slashed its full-year outlook for the medical unit, citing the weak macroeconomic environment. Canon now expects full-year medical system sales of ¥469 billion ($4.3 billion), down 10.5% from its earlier forecast.