Mass consolidation is sweeping up small medtech organizations. Med device startups and early-stage companies that want to be ...

As technical demands continue accelerating across life sciences, pharmaceuticals, and aerospace, organizations are increasingly recognizing that innovation cannot happen in isolation. A recent Forbes ...

Across Latin American medical device markets, the local authorized representative that holds or manages the regulatory asset ...

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 ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...

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 ...

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 ...

To appreciate Stryker’s purchase of MAKO Surgical, we need to jump in the time machine and travel back to the turbulent healthcare environment of 2012. Although the Affordable Care Act (ACA) was ...

Across industries, innovation platforms constantly monitor device usage and anticipate future needs, fueling breakthrough ideas in real time. AI agents are dissolving silos in large organizations, ...

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 ...