Philips (NYSE:PHG) landed 510(k) for its next-gen AlluraClarity, a live image X-ray system with lower radiation doses and more sophisticated software, according to a press statement.
This imaging software, called ClarityIQ, will be offered as an upgrade to hospitals that do not want to replace existing monoplane and biplane interventional X-ray systems, the company said.
“The transition from highly invasive surgical procedures to minimally-invasive image-guided therapies, with all their intrinsic patient benefits, is a transformation in the delivery of healthcare that is rapidly accelerating around the globe," Gene Saragnese, CEO of Imaging Systems at Philips Healthcare, said in prepared remarks.
The clearance comes on the heels of an FDA Class I recall of Philips’ V60 ventilator, made by subsidiary Respironics. The recall affects more than 19,000 units of the company’s ventilator systems.
