FDA approves Kubtec’s new digital X-ray system

20 November 2014 (Last Updated November 20th, 2014 18:30)

US-based developer of low dose digital radiography (DR) systems Kubtec has received approval from US Food and Drug Administration (FDA) for its low-dose portable digital X-ray system, KUB 250.

US-based developer of low dose digital radiography (DR) systems Kubtec has received approval from US Food and Drug Administration (FDA) for its low-dose portable digital X-ray system, KUB 250.

The new high resolution, compact and lightweight imaging system was developed for neonatal intensive care unit (NICU).

Kubtec said when imaging high risk infants in the NICU, it is important to track subtle changes in pathology, and to focus on low dose.

Existing digital X-ray systems maintain pixel resolution in the 150-170 micron range, sacrificing high resolution images to keep the radiation dose low.

"The new high resolution, compact and lightweight imaging system was developed for neonatal intensive care unit (NICU)."

Poor image quality means other facilities may be required to take additional X-rays of the infant to confirm pathology or peripherally inserted central catheter (PICC) line placement, which defeats the purpose of imaging with reduced radiation exposure.

Kubtec research and development director Chester Lowe said: "The KUB 250 has been clinically tested to reduce radiation exposure by up to 40% with our advanced high resolution imaging technology.

"Detailed image enhancement tools and 750 ms image readout reduce the need to re-image these fragile patients, eliminating further potential radiation exposure."

The company said the KUB 250 can image with 96µ resolution and eliminates the need to take additional X-rays, minimising radiation dose to the infant by as much as 40% for each acquired image.

KUB 250 features an articulating arm for decubitus views and a lightweight digital radiography (DR) detector that slides directly into the incubator slot, avoiding the need to move the neonate and reducing stress.