Carestream’s digital imaging technologies get FDA approval

Carestream’s Dual Energy imaging technology and also its Focus 35C Detector with Image Suite Software have secured 510 (k) clearance from the US Food and Drug Administration (FDA).

Powered by Carestream’s Eclipse image-processing engine, the dual-energy application utilizes a couple of filter materials which are switched automatically between the high- and low-energy exposures. This helps in producing a soft-tissue-only image without bone structures and also a corresponding image showing only the bones, said the medical imaging systems provider.

According to Carestream, this differential filter method streamlines both X-ray spectrums thereby getting optimal dose efficiency. Furthermore, it is also said to generate exceptional image quality at the equivalent patient exposure as a standard, non-Dual-Energy posterior-anterior chest radiograph, said the company.

Carestream’s Dual-Energy technology has been approved for chest X-rays on the DRX-Evolution Plus System.

Carestream Focus 35C Detector. Photo courtesy of Business Wire.

Sarah Verna – Carestream Worldwide Marketing Manager for Global X-ray Solutions said: “When performing a standard chest X-ray, you see both soft tissue and bone structures overlaying on top of each other.

“Dual-Energy will help radiologists improve the specificity and sensitivity for chest diagnosis because of both material differentiation and the removal of overlapping anatomical structures.”

The new Focus 35C Detector with Image Suite Software brings together advanced image processing with larger functionality to transform an analog X-ray into a 100% wireless digital radiography system, thereby making it an economical retrofit solution. Paired with the Image Suite Software, the Focus 35C Detector offers a mini Picture Archiving and Communication System (PACS) to deliver a complete imaging package to help customers benefit from all the capabilities of a PACS without the need of investing in all the features of a larger system.

Focus 35C Detector is expected to see a commercial launch by the end of this year. On the other hand, the Dual-Energy technology is anticipated to be available for customers from early 2020.

Carestream, Dual Energy imaging technology, Focus 35C Detector, Sarah Verna, US FDA, US Food and Drug Administration, USA