US-based Clear Guide Medical has received CE mark approval for its Clear Guide ONE, allowing the firm to sell the medical device in European Union’s 28 member states, as well as Iceland, Norway, Liechtenstein, Switzerland and Turkey.
By using computer-assisted image guidance (CAIG), the Clear Guide ONE will allow clinical personnel to see the needle or catheter path on the ultrasound display before entering the patient body.
Clear Guide Medical regulatory affairs and quality system director Jack Kent said: "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."
According to the company, the Clear Guide ONE is intended for use in procedures where ultrasound is currently used for visualization and can be attached to most commercially available ultrasound systems.
The Clear Guide ONE also received approval from the Food and Drug Administration (FDA) for sale in the US, as well as obtained the Health Canada Medical Device Licence.
Currently, clinical studies are underway to measure the performance improvements of clinicians using the Clear Guide ONE.