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 ...

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 ...

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

In the previous article, “How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint,” we discussed key factors for maintaining operational excellence to achieve cost reduction ...

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 ...

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 ...

Medtronic has acquired Smith & Nephew’s gynecology business, including a minimally invasive surgical solution, for $350 million. Senior executives from both companies remarked that the acquisition ...

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 ...

Medical device developers are likely more than familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how ...