Carestream scores FDA approval for two new imaging technologies

Rochester, New York-based Carestream recently earned 510(k) clearance from the Food and Drug Administration for two new pieces of imaging tech.

Those include the company’s cost-conscious Focus 35C Detector and its Dual-Energy imaging application, which uses two filter materials to automatically switch between high- and low-energy exposures. The latter allows radiologists to produce images of just soft tissue, removing any bone structures, along with bone-only images, too.

“When performing a standard chest x-ray, you see both soft tissue and bone structures overlaying on top of each other,” Sarah Verna, worldwide marketing manager for global x-ray solutions at Carestream, said in a company announcement. “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.”

Meanwhile, the Focus 35C Detector is an option for smaller imaging facilities who are on a budget. It’s a product that can be retrofitted to existing technology, transforming older, analog x-ray suites into a “full wireless digital radiography system,” the company noted. Paired with Carestream’s Image Suite Software, it provides practices with a mini PACS without the sizable investment that comes with a larger system.

The Focus 35C Detector should hit the market by the end of 2019, while Dual-Energy is expected for an early 2020 release, Carestream said.