Philips' camera-guided digital imaging system gets FDA OK
- FDA has granted 510(k) clearance to Philips' DigitalDiagnost C90 radiography system, the Dutch company announced Wednesday.
- The device displays a live camera image at the tube head, a first for radiography, according to Philips, providing views of the body areas being scanned during the patient positioning process.
- The nod comes after Philips reported fourth quarter 2018 double-digit growth in image-guided therapy and ultrasound and low single-digit growth in diagnostic imaging.
The precision medical imaging market is on track to hit $8 billion by 2027, up from $120 million in 2017, according to a recent Frost & Sullivan report.
While advances such as image-based 3D printing are fueling the push toward personalized care, imaging's role in diagnostics is likely to grow as physicians seek to individualize treatment approaches for better outcomes. Other growth opportunities lie in evidence-based study ordering, adaptive radiation therapy and personalized image acquisition protocols, the Frost & Sullivan analysts said.
The DigitalDiagnost C90 system includes the Philips Eleva user interface found in a range of the company's other digital radiography systems. The platform cuts time by 17% per examination, Philips said.
The new system also helps to reduce patient care costs through flexible room configuration options and availability of SkyPlate sharing among all Philips premium digital radiography systems, the company said.
In reporting fourth quarter results, the company blamed U.S. and Chinese tariffs for a "more challenging environment" that held growth in comparable sales to 5%.
Still with orders up 10% in the fourth quarter, Philips maintained its forecast of 4% to 6% sales growth in 2019. Total sales for the quarter were $6.4 billion, in line with Philips' year-end targets.
Philips CFO Abhijit Bhattacharya has said the company will relocate some of its U.S. and China production to ease the impact of the trade war, which has contributed to weaker performance in North America.