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 electronic registration certificate for medical devices will be fully implemented, from November 1, 2022.
After October 2020, when the electronic certificates for domestic class...
The declining sales of Covid-19-related products worldwide highlight that the world is shifting its focus away from the pandemic. The demand for Covid-19 tests...
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...
ISO 14644 family of standard defines the requirements for cleanroom environment, thus where sterile devices need to be manufactured. Specifically, ISO 14644 is the international...
