Company Product Description Indication Status
Biocartis Group NV, of Mechelen, Belgium Idylla SARS-CoV-2 test Fully automated RT-PCR test For the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swab specimens Received the CE mark
Icotec AG, of Altstaetten, Switzerland Vader Pedicle system Pedicle screw manufactured with a carbon/PEEK material, and Ti-iT pure titanium coating on the screw shaft Restores the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion Received 510(k) clearance from the U.S. FDA
Materialise NV, of Leuven
Belgium
Personalized orthopedic and cranio-maxillofacial (CMF) solutions Includes 3D-printed anatomical models and patient-matched surgical guides and implants For use in orthopedic and CMF surgical operations Received the CE mark
Medcad, of Dallas Accuplan Software and image segmentation system for the
transfer of imaging information from a medical scanner
For planning maxillofacial surgery Received 510(k) clearance from the U.S. FDA

Notes

For more information about individual companies and/or products, see Cortellis.