U.S. medical device companies seeking funding this year will find that innovative tech and a stand-out prototype aren’t ...

When analyzing the drug delivery product pipeline, three key technologies stand out. Check out the latest market research.

Growing patient demand and limited clinical capacity are straining modern care. Assistive technologies help standardize procedures, reduce variability, and enable consistent, high‑quality outcomes.

As regulations continue to shift, staying current with the latest expectations is essential for maintaining compliance and ...

AI server racks now exceed 100 kW, reshaping datacenter power design. Learn how evolving capacitor technologies enable stable, efficient power conversion in next-generation AI infrastructure.

As routine labs, imaging, and information from wearables and the environment stream in, a digital twin can model trajectories ...

Manufacturers must cut decision delays, harness AI to unlock messy data, embrace adaptive automation, and empower teams to ...

AI is reshaping quality in life sciences, but many teams struggle to balance innovation with audit readiness. Learn how industry leaders are managing risk and building confidence with AI.

The FDA’s traditional classification system effectively labels a medical device’s clinical risk, but it is a poor predictor of how easily that same device can be hacked. While a Class III implantable ...

Within the EU's regulations, Article 10(9) refers to quality system requirements under Annex IX. This is a specific requirement concerning quality control for the devices that use AI technology under ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

The wearable medical device industry sits at the intersection of life sciences regulation and rapidly-evolving technology law. Companies in this space face overlapping legal frameworks that can ...