EYSINS, Switzerland, Feb. 10, 2025 /PRNewswire/ -- AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex ® Celiac ...

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of ...

Senseonics (SENS) announced it has filed for CE Mark registration for the Eversense 365 CGM system.Maximize Your Portfolio with Data Driven ...

The Eversense 365 CE Mark submission was prepared in compliance with the EU Medical Device Regulation (MDR) and, upon approval, would enable the commercialization of Eversense 365 in European ...

today announced it has filed for CE Mark registration for the Eversense® 365 CGM system. Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US ...

(RTTNews) - Senseonics Holdings, Inc. (SENS) a medical technology company has announced the completion of its CE Mark submission for the Eversense 365 Continuous Glucose Monitoring or CGM system ...

Once the CE mark is obtained, a device can be marketed and sold in Europe and other areas that rely on the CE mark. BSI Group will serve as the notified body for Modular Medical for its CE clearance ...

NAU provost Karen Pugliesi said NAU had started efforts to expand its health programs a few years earlier as part of the ...

Hungry Hearts Cabaret and Love Advice Show returns for an 11th season as Valentine’s Day is just around the corner.

Obtaining the CE Mark follows years of effort and substantial investments in catheter development, testing, manufacturing, and preclinical and clinical research. Clinical experience with MAGiC in ...

Three weeks in, the change the Trump administration has brought is a disruption of the federal government on an unprecedented scale, dismantling longstanding programs, sparking widespread public ...