Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical ...

The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling ...

Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now ...

The global healthcare ecosystem is undergoing a rapid transformation, driven by technological advancements and a growing demand for personalized treatments. Among these innovations, smart drug ...

We are sure you are aware that the EU medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the ...

Explore the critical aspects of ophthalmic drug and device testing, emphasizing regulatory and patient compliance. It highlights the importance of ensuring safety, efficacy, and adherence to stringent ...

Medical device labeling must show many elements, such as manufacturer information, product information, intended use, indications for use, instructions for use, information regarding sterile ...

As mental health disorders continue to climb globally — now affecting nearly 1 billion people — the need for earlier detection, continuous monitoring, and more personalized interventions is more ...