The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. U.S. manufacturers undergo frequent, unannounced inspections, foreign ...

Lab IoT adoption is growing, and recent innovations make it more promising than ever. See how IoT advances can unlock new standards of equipment uptime. Keeping lab equipment operational is crucial ...

Introduction: A Wake-Up Call from Recent History In the world of MedTech, traditional development processes often slow down innovation. Medical device manufacturers face an environment where global ...

As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical records. EMRs remain both vital and frustrating. Clinicians wrestle with ...

For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR ...

Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives are at stake. The implications of quality culture extend beyond operational efficiency; they ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges. Artificial Intelligence (AI) and Machine Learning ...

This blog explores the transformative potential of AI assistants in healthcare management and delves into the benefits for providers, medical assistants, and obviously, patients. Imagine the daily ...

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s ...

In February, Hologic received FDA clearance for its Genius Digital Diagnostics System, which combines advanced imaging with AI-assisted review for cervical cancer screening. We spoke with Mike Quick, ...