FDA Clears New CT Systems for Diagnostic Radiology and Radiation Therapy Applications

The Food and Drug Administration (FDA) has granted 510(k) clearance for new computed tomography (CT) systems, including the diagnostic radiology-focused Rembra CT as well as the Rembra RT and Areta RT systems for radiation therapy applications.

Philips, the manufacturer of the CT systems, said the Rembra CT provides rapid image acquisition and reconstruction capabilities in high throughput settings such as emergency departments and critical care. The Rembra CT device can reportedly be utilized for up to 270 CT exams a day, according to Philips.

In addition to facilitating radiation therapy planning workflows, Philips said the Rembra RT and Areta RT platforms have an 85 cm extended field of view and 4D CT capabilities to provide more precise targeting of tumors in radiation treatment.

“As health-care systems manage increasing demand and complexity, imaging plays a critical role in enabling timely and informed clinical decisions,” said Dan Xu, the business leader of CT at Philips. “With the Rembra platform, we are redefining what clinicians can expect from CT, combining speed, scalability, and precision to expand access to high-quality imaging while supporting confident diagnosis and highly accurate treatment planning.”