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

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 ...

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 ...

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 ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

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

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 ...

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.

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 ...

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 rapid development of technology has changed how patients manage their health and interact with healthcare professionals. Software as a medical device (SaMD) has grown in market share and ...