EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease...

The article provides an overview of the applicable regulatory requirements for ethical considerations in the context of clinical investigations of medical devices initially intended...

The FDA recently approved LimaCorporate’s fully 3D-printed glenoid baseplate and humeral stem for use in reverse shoulder replacement. The shoulder includes the glenohumeral joint, which...

The new article describes the types of medical devices covered by the scope of the guidance and highlights the key points to be taken...

The new article describes in detail the main concepts used in the context of medical device recalls and enhancements in terms of determination of...