SonoSite Inc. (NSDQ:SONO) won 510(k) clearance from the Food & Drug Administration for its LumenVu catheter guidance system.
The Bothell, Wash.-based portable ultrasound maker said it designed the system to increase the accuracy of peripherally inserted central catheter placement. Physicians incorrectly place 30 percent of peripherally inserted central catheters, according to the company.
By using near-infrared technology with a fiberoptic stylet, the LumenVu allows clinicians to visualize a catheter tip as it travels through a blood vessel, SonoSite said.
The company is also seeking European clearance for the system. Several hospitals on the continent are currently evaluating the catheter guidance system, according to a press release.
The clearance is more good news for the company, where new acquisitions have been making it rain for the past year. The company posted a 341 percent profit increase for the second quarter, with net earnings of $1.9 million on sales of $61.5 million.