The regulatory clearance covers the t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology.

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

The Libre Duo systems are the first glucose-ketone monitors to reach the diabetes market.

With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better ...

Abbott (NYSE: ABT), a global healthcare leader, announced today it has secured CE Mark for the world's first dual ...

The UKCA mark was introduced in the Great British (GB) market to replace the European CE mark following Brexit. Products which require a CE mark in the EU must comply with the UKCA marking regime if ...

CE mark certification comes after Hong Kong-based Cornerstone Robotics raised $200 million in November to accelerate its ...

Cornerstone Robotics announced today that it received CE mark approval for its Sentire endoscopic surgical robotic platform.

Developed, tested, and selected from more than 200 formulations Unique long-chain chemistry formulated and optimized for 3D printing Pioneers a same-day digital denture solution with three times the ...