Philips has received clearance from the U.S. Food and Drug Administration (FDA) to market the DigitalDiagnost C90, its new digital radiography system. It is designed to increase patient throughput and decrease the time to diagnosis, Philips promises.
“X-ray is often the start of a patient’s care journey and plays a critical role in supporting clinical care decisions from that point forward – making high-quality imaging essential”, Philips says in a statement. “As the industry’s first radiography unit with a live camera image directly displayed at the tube head, DigitalDiagnost provides a clear view of the anatomical area being scanned during the patient positioning process – improving workflow so that clinicians can be confident that the right area is captured with a low X-ray dose exposure.”
FDA
The approval by the FDA is very welcome for the Dutch health tech company. Philips has had a troublesome relationship with the FDA. In 2017, Philips was ordered to tighten controls on its manufacturing facilities in the United States. Inspections between 2009 and 2015 revealed that Philips did not meet all quality requirements for the production of defibrillators. The enhanced supervision by the FDA was applied for a period of five years.
iF Design Awards
Philips claims that thanks to the DigitalDiagnost C90’s Eleva Tube Head, the workflow can be speeded up by over 17% per examination. “Its touch screen display transfers operation into the examination room to allow for more time with the patient.” The design of the DigitalDiagnost C90’s Eleva Tube was recently recognized by the prestigious iF Design Awards in the categories of both product and service/user experience design.