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

The most expensive decision a U.S. medical device company makes in Latin America is rarely the one its leadership team has on the agenda. It is not the choice of country. It is not the product ...

In micro molding, automation is far more than robotics on the factory floor—it is the manufacturing architecture that enables quality, scalability, and repeatability. While conventional molding ...

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 ...

As liquid biopsies, wearables, multi-omics, and AI mature, diagnostics could become the operating system of healthcare: a continuously learning layer that turns everyday data into earlier action.

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 ...

In today’s environment, medtech companies can no longer build their strategy around regulatory timelines alone. With market dynamics shifting, regulatory expectations evolving, and business continuity ...