Roche Secures FDA CLIA Waiver and CE Mark for Bordetella POC Test
Roche has received CE Mark approval for its first point-of-care test capable of diagnosing and differentiating Bordetella infections, including whooping cough, within 15 minutes. The rapid, PCR-accurate test enables faster clinical decisions and supports early intervention, particularly for vulnerable groups such as infants and the elderly.
CE Mark | 03/12/2025 | By Dineshwori | 101
Roche receives CE Mark for AI-based Kidney Klinrisk Algorithm
The new CKD algorithm panel, available on the Navify Algorithm Suite, marks a step in Roche’s strategy to provide digital health solutions for the growing global burden of CKD.
CE Mark | 07/10/2025 | By Dineshwori | 208
AVITA Medical Receives CE Mark for RECELL GO
With the CE Mark secured, AVITA Medical will begin commercialisation of RECELL GO in select European countries, including Germany, Italy and the United Kingdom, in collaboration with burn centres and clinical partners.
CE Mark | 17/09/2025 | By Dineshwori
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