FDA clears mobile C-arm system for complex vascular imaging
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Key takeaways:
- The FDA issued 510(k) clearance for a motorized C-arm imaging system for complex vascular procedures.
- The motorized system can be controlled from the tableside and also comes in nonmotorized configurations.
Royal Philips announced the FDA 510(k) clearance and launch of image-guided therapy mobile C-arm system designed for complex vascular needs and clinical procedures such as cardiac interventions, pain management and urology.
The motorized C-arm system (Zenition 90 Motorized) allows clinicians to control it from the tableside and is designed to improve clinical efficiency with automated workflows, touchscreen image controls and the advanced software solutions, according to a press release from the company.
The new C-arm system is also available in a nonmotorized configuration, according to the release.
“During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,” Mark Stoffels, business leader at Philips Image Guided Therapy Systems, said in the release. “The new Zenition 90 Motorized empowers medical teams to confidently perform a wide range of interventions while achieving the best possible outcome for their patients.”
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