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.

Manufacturers must cut decision delays, harness AI to unlock messy data, embrace adaptive automation, and empower teams to act as force multipliers. See how these shifts define the path to resilience.

AI is reshaping quality in life sciences, but many teams struggle to balance innovation with audit readiness. Learn how industry leaders are managing risk and building confidence with AI.

Selecting the right prefillable syringe (PFS) is a critical decision that directly impacts the interface between a drug and a patient. For emerging biotech companies, the traditional approach of ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

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

This article discusses why Colombia, despite the global effects of the COVID-19 pandemic, has become the country with the best commercial advantages in South America and one of the three best in Latin ...

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 ...

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 ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

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 ...

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 ...