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

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

In micro medical manufacturing, prototype success doesn’t guarantee production success. Learn how tolerance strategy, tooling ...

In micro molding, automation isn’t an add-on. Learn how integrated handling, inspection, and packaging enable scalable, ...

In emergencies, scarce data delays decisions. Remote sensing — radar, thermal, and vision — assesses patients at a distance, ...

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 ...

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, ...

Women’s History Month is a time to celebrate progress, but for those of us in medical technology, it must also be a time of reckoning. While women represent 50% of the global population, a silent, ...

Raising funds in the medical device industry is always challenging. Doing so as a startup can be even more so. And U.S. medical device companies seeking funding this year will find that innovative ...

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 ...

A failed Bowie-Dick test signals more than a minor setback; it’s a warning that your sterilizer may not be achieving the conditions required for effective steam sterilization. These failures can lead ...