The FDA has granted 510(k) clearance to Philips’ two-in-one digital radiography-fluoroscopy device. Philips’ system, ProxiDiagnost N90, combines features from other existing products to enable users to perform nearby fluoroscopy and digital x-rays using a single device.
In bringing the technologies together into a system based on its EasyDiagnost Eleva, Philips has given radiologists the means to capture still and video images without switching between devices. And, as all the underlying technology is already FDA cleared, the Dutch healthcare company got the green light to sell the system under the 510(k) pathway without running a clinical study.
Like the predicate device, ProxiDiagnost N90 is FDA cleared for use in all routine radiography and fluoroscopy situations, plus some specialist fields such as angiography and pediatrics.
The difference is ProxiDiagnost N90 incorporates fixed and wireless detectors from Philips’ Pixium and SkyPlate product lines, plus an image chain acquisition station and workflow from its Eleva Workspot. The result is a system Philips thinks is better suited to the needs of radiographers and the sites that employ them.
“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,” Sandra Burghardt, senior director of global marketing for diagnostic x-ray at Philips, said in a statement.
The new product slots into a diagnostics and treatment business unit that enjoyed a strong end to 2017. Sales in the fourth quarter were up 6%, twice the level Philips achieved over the year as a whole.