The EU’s proposed orphan and breakthrough device designations would formalise accelerated regulatory pathways for high-need medical technologies, with significant implications for conformity ...

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...

At the end of 2025, the European Union advanced significant initiatives aimed at modernising and strengthening the regulatory framework for the ...

Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory ...

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

Glaukos has secured European Union Medical Device Regulation (EU-MDR) certification for its iStent infinite, along with other micro-invasive glaucoma surgery (MIGS) technologies, including the iStent ...

The agreement, finalised after protracted negotiations, eliminates or drastically reduces tariffs on pharmaceuticals, chemicals and medical devices, while also opening new pathways for Indian medical ...

The so-called “mother of all deals” lowers import tariffs on European pharma exports from 11% to zero and also eliminates ...

Dr. Eckhard Alt, MD, PhD, Executive Chairman of InGeneron, Inc. stated that receipt of MDR certification marks an important milestone in the Company's continued ability to provide cell therapy medical ...