Philips receives U.S. FDA 510(k) clearance to market ProxiDiagnost N90, its premium digital radiography and nearby fluoroscopy system
Two-in-one Digital Radiography-Fluoroscopy system provides low-dose, high-quality images while supporting fast workflow, broadening clinical capacity and increasing room utilization
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ProxiDiagnost N90, its newest premium Digital Radiography-Fluoroscopy (DRF) system. With its ability to perform both nearby fluoroscopy and digital X-rays through a single system, ProxiDiagnost N90 supports high room utilization and increased patient throughput, while also providing outstanding workflow support and patient accessibility.
Benefits of the new system for both patients and staff include:
Enhanced image quality – The ProxiDiagnost N90 provides high-quality images with premium flat detector technology and the new dynamic UNIQUE image processing, thanks to which sequences are stable and harmonized from the first frame to the end. This eliminates the need for several frames to produce a usable image and make a confident diagnosis.
Support for staff workflow – With support for nearby use, ProxiDiagnost N90 allows technologists to conduct procedures next to the patient, in keeping with common workflow and to improve the patient experience. The system also features the Philips Eleva user interface, allowing clinicians familiar with the design to use the system immediately without additional training due to Philips’ platform approach for the design of its premium portfolio.
Greater patient accessibility – Thoughtful design, including a small footprint and an open overhead area and table, enables technologists or caregivers to be closer to the patient during procedures. This is especially important for pediatric and elderly patients, or others who may need additional support to remain calm during the procedure.
For pediatric examinations – Philips’ Grid-Controlled Fluoroscopy (GCF) enables a dose rate1 reduction up to 68%2 compared to Pulse Controlled Fluoroscopy (PCF), depending on patient type and clinical application.
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.
Senior Director of Global Marketing for Diagnostic X-ray at Philips.
“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,” said Sandra Burghardt, Senior Director of Global Marketing for Diagnostic X-ray at Philips. “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.”
1 Dose rate determined according to IEC 60601-2-54, 220.127.116.11.5.102, System set up: detector format 43 x 43 cm (17 x 17”), patient type children, 0.1 mm Cu + 1 mm Al filter, reduced dose and pulsed slow fluoroscopy mode with 2 pulses/s, Phantom: 5 cm (2 in) PMMA.
2 Relative difference of two reference air kerma rates between system with GCF and system with PCF
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips' health technology portfolio generated 2017 sales of EUR 17.8 billion and employs approximately 74,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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