I n t e l l i g e n t D e s i g n a n d D e v e l o p m e n t | |
| PRESS RELEASE
"Lucent Medical Systems Receives FDA Clearance for Zortran Detector" 510(k) Clearance from the US Food and Drug Administration for the Zortran catheter detector
Kirkland, WA - Lucent Medical Systems announced today that it received marketing (510(k)) clearance from the U.S. Food and Drug Administration (FDA) for the ZortranTM catheter detector. The Zortran detector is a hand-held magnetic sensor system that quickly locates and displays the three-dimensional position and orientation of specially designed, magnet-tipped Peripherally Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during or after initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities, or home-care settings. BD Medical Systems has licensed the Zortran technology for use in the field of vascular access. Lucent Medical Systems President and Chief Technical Officer Robert Golden said, "This milestone is an exciting achievement for the company, and demonstrates Lucent's ability to fully develop a complex medical device from generation of an initial concept through regulatory approval." Lucent Medical Systems (www.lucentmedical.com) was founded in 1994 to commercialize medical inventions based on research first conducted at the University of Washington. The company's initial goal was to develop a family of systems for non-invasive determination of position, orientation and motion of devices inserted in the body such as enteral feeding tubes, tracheal tubes, peripherally inserted central venous catheters and surgical markers. Lucent has recently expanded its original focus and is also developing new medical devices for the fields of urology and vascular access. | |
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