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 ...

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

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 ...

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 ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

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 ...

The medical device market in India is one of the best places for the world to tap into since the early 2000s. Many are watching the evolution of the medical device industry in India, with McKinsey and ...

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 ...