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

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 ...

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 ...

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

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...