Medical Device | January 01, 2026
WORK Medical scores regulatory approval for AI-powered blood analyzer
It performs white blood cell differential counts and quantifies red blood cell and platelet morphology,
It performs white blood cell differential counts and quantifies red blood cell and platelet morphology,
The study will run across 18 sites and enroll roughly 200 patients over 24 months
The agreement to sell B Medical Systems marks a major step forward in simplifying the portfolio to prioritize our core capabilities with the highest strategic impact
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
The cancellation underscores the regulator’s strict stance against misleading cosmetic claims
The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities
Study published in laboratory investigation, the official journal of the United States and Canadian Academy of Pathology
AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life
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