Finnish medical device firm Bioretec has submitted an application seeking CE mark for its bioresorbable RemeOs trauma screw to commercialise in the European Union (EU).
The magnesium alloy trauma screw is part of the company’s new RemeOs product family.
It is designed to fix bone fractures (osteosynthesis) as well as after osteotomies such as the correction of deformities or malalignments.
The RemeOs bioresorbable magnesium implant allows the bone to heal and is designed to be replaced by bone naturally.
It also eliminates removal surgeries which are required in several cases while using traditional implants.
The company aims to receive the CE mark and launch the new RemeOs product into the EU markets this year.
Bioretec CEO Timo Lehtonen said: “Filing for the CE mark on schedule is an important milestone in the commercialisation of our first RemeOs product and a great end to our first year as a listed company.
“I am proud of our team’s commitment and effort to reach this milestone. It follows our strategic goal of developing and commercializing innovations that increase patients’ quality of life.”
The company stated that its new RemeOs product line is being developed using a magnesium alloy and hybrid composite.
Furthermore, the RemeOs implants facilitate fracture healing.
Last month, LumiraDx secured CE marking for its SARS-CoV-2 & Flu A/B Antigen Test, which can detect and differentiate SARS-CoV-2, influenza A, and influenza B viral antigen simultaneously.
Using nasal swab samples, the microfluidic immunofluorescence assay provides results within 12 minutes. Shipment of the test is expected to begin in the coming days.