Clear Guide Medical announces that its first clinical product, the Clear Guide ONE, has received the CE Mark from its Notified Body. The CE Mark allows the marketing and sale of the medical device in 28 Member States of the European Union, as well as Iceland, Norway, Liechtenstein, Switzerland and Turkey. Jack Kent, Director of Regulatory Affairs and Quality System, elaborated on the CE Mark’s importance: ”This certification will open global commercialization opportunities in other regions that leverage the CE Mark as a basis for regulatory review. We are currently seeking marketing authorizations in Australia and New Zealand, and we expect to expand to other countries and regions as soon as possible.”
Earlier, the Clear Guide ONE was cleared by the Food and Drug Administration (FDA) for sale in the United States. It has also received the Health Canada Medical Device Licence.
Insert with confidence. The Clear Guide ONE revolutionizes the practice of interventional medicine with a compact, ergonomic, easy-to-use ultrasound probe attachment. No specialized instrumentation, sensors, or time-consuming calibration steps are required to use the Clear Guide ONE. With the Clear Guide ONE, guidance is “always on” – helping physicians hit their target quickly and easily. The Clear Guide ONE is intended to be used in procedures where ultrasound is currently used for visualization. It can be attached to most commercially available ultrasound systems, making ultrasound guidance available for most needle- and catheter-based procedures and simple for everyone to use.
ABOUT CLEAR GUIDE MEDICAL
Clear Guide Medical, a privately-held company headquartered in Baltimore, MD, develops innovative technologies to provide Computer-Assisted Image Guidance (CAIG) for needle-based interventions. By using CAIG, the Clear Guide ONE enables clinical personnel to see the needle or catheter path on the ultrasound display before entering the patient body. Understanding the correct angle at which to insert needles or catheters into the body is essential to good clinical outcomes. The Clear Guide ONE adapts to most commercial ultrasounds, increasing the utility of that equipment. Clinical studies to quantify the performance improvements of clinicians using the Clear Guide ONE are currently underway.
The Clear Guide ONE and the Clear Guide EDU training system are currently available for sale in the United States, the European Union and Canada by contacting firstname.lastname@example.org.