A systemic bias in medtech design continues: a failure to account for female-specific data. Teams often resort to a dangerous ...

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 ...

Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that ...

Growing patient demand and limited clinical capacity are straining modern care. Assistive technologies help standardize ...

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 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 ...

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

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 ...

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 ...

Having a common understanding of the functional utility for each stage of prototype development is essential to managing the expectations for everyone involved in a project, from the designers to the ...