As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in ...

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...

For instance, in October 2022, Freyr partnered with an orthopedic implant manufacturing company in Korea, and as per the agreement, provided it with regulatory device registration and legal ...

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Apple is still facing headwinds in China. The company's overall sales in China declined 11.1% during to $18.51 billion during ...

New satellite services are in development which will permit satellites to communicate directly with unmodified end user phones. These services ...

A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device ...

Considering the lack of regulatory provisions further posing risks to patient safety, the Central Drugs Standard Control ...