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 ...

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 ...

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

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 ...

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 beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

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 ...

On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully ...

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, ...