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.

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

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

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.

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

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

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

Each clause contains the requirements as well as sub-clauses, which support the main clause by providing the details of the standard’s requirements for a QMS. For the purposes of this article, 21 CFR ...

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 ...