Search Tag: CE Mark
2020 12 May
- Ortho’s COVID-19 total antibody test receives CE Mark -Ortho’s total antibody test may be used as aid in diagnosis and to support decisions for getting people back to work -The test offers excellent performance, with 100 percent specificity and sensitivity -Ortho began shipping its antibody test to customers in highly impacted geographies and plans...Read more
2019 26 Nov
Wire-free lesion localization tags can now be implanted for more than 30 days, creating greater flexibility for providers and patients during breast-conserving surgeries Hologic today announced the extension of the CE Mark for its LOCalizer™ radiofrequency identification (RFID) tag for long-term placement. The tag can now be implanted more than...Read more
2017 12 Jan
Abbott has announced its Alinity™ s System for blood and plasma screening received CE Mark and is now available in Europe and other countries that recognize CE Mark. The new testing solution is designed to screen blood and plasma faster and more efficiently within a smaller footprint than Abbott's current systems. In a testing specialty that can require extensive...Read more
2016 25 May
Advanced Cooling Therapy (ACT) has received CE Mark approval for an expanded indication for use of its Esophageal Cooling Device (ECD). The ECD, the only temperature management device to modulate patient temperature using the esophageal space, now has CE Mark approval for use up to 120 hours in patients who need either warming or cooling. ...Read more
2016 29 Feb
EOSapps Suite for Spine, Hip and Knee Surgery Planning to be Featured along with the EOS System at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting Company to Present at Canaccord Genuity Musculoskeletal Conference at AAOS EOS imaging, the pioneer in 2D/3D orthopedic medical imaging has announced that it has received...Read more
2015 01 Jul
System addresses unmet need for continuous glucose monitoring in the ICU, a potential market in excess of $5 billion GlySure Limited has announced that it has secured the CE Mark for the world’s first and only Continuous Intravascular Glucose Monitoring System (CIGMS). The initial use of the GlySure™ CIGMS is to enhance blood glucose management...Read more
2014 25 Apr
The agreement includes CE Mark performance evaluation and doubles the Hospital’s prospective trial of 20 cancers, adding a range of additional vital background work VolitionRx Limited, a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, has announced that VolitionRx has extended its agreement...Read more
2013 01 Nov
It was announced that Beckman Coulter has received the CE Mark approval for Access 25 (OH) Vitamin D Total assay for use on the Access 2 and UniCel DxI series of immunoassay system, an important addition to the company’s bone metabolism assay menu. Arnd Kaldowski, President of Beckman Coulter Diagnostics, is confident that the European CE Mark...Read more