Philips wins FDA nod for ProxiDiagnost N90 radiography-fluoroscopy system

Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its ProxiDiagnost N90 digital radiography-fluoroscopy system. The newly cleared system is designed to perform both nearby fluoroscopy and digital X-rays to support more efficient room utilization and improve workflows, the Amsterdam-based company said. Philips said that the ProxiDiagnost N90 is designed to provide enhanced, high-quality images using premium flat detector technology, improved support for staff workflow, increased patient accessibility and increased dose rate reduction for pediatric examinations. “As a dual-use system, ProxiDiagnost N90 meets key dimensions of healthcare’s Quadruple Aim and is a smart choice for healthcare organizations that need a new fluoroscopy solution – particularly those in the U.S. that follow a nearby use method. We are setting the bar higher and enabling a confident diagnosis from the first frame. ProxiDiagnost N90 gives radiologists and technologists the ability to capture high-quality still or video images in a way that aligns with their workflow and provides an improved patient experience,” Philips diagnostic X-ray global marketing senior director Sandra Burghardt said in prepared remarks. Earlier this month, Philips said it was continuing to divest itself of its legacy lighting business, selling off approximately $641.8 million (EUR €520.7 million) in shares of Philips Lighting. The post Philips wins FDA nod for ProxiDiagnost N90 radiograp...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance royalphilips Source Type: news