Device

Executive Summary Combination products-integrating drugs, devices, and often biologics-have transformed the medical devices industry, driving innovation, partnerships, and new regulatory frameworks. Since the early 2010s, this sector has experienced exponential growth, fueled

In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) this April issued a long-anticipated rule overhauling how Laboratory Developed Tests (LDTs) are regulated. The rule aligns

Artificial intelligence (AI) has become one of the most exciting and promising technologies in health care and MedTech, thanks to its ability to shift through huge volumes of data and quickly detect

Internationally adopted standards play a crucial part in underpinning regulatory and quality operations. Additionally, they help advance translational science and improve traceability within the global supply chain. The International Organization for Standardization

10 Risk Management and Other Cybersecurity Considerations for Connected Medical Devices 9 What Patients Expect Out of Their Wearable Medical Devices 8 Preparing for MDR: Don’t Forget about Class I Reusable Devices 7 Trends in

Some Asian countries are racing to ease import restrictions for needed goods that could save lives. Also, the Asian private sector is unveiling a raft of new artificial intelligence, telehealth and data