Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, ...

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 ...

Originally CE marked in 2021 for limited to high-risk patients only, .Abbott has now received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and ...

The physician has a unique perspective that non-clinical investors don’t: they know firsthand whether a technology will be adopted. They deeply understand if it truly is better for them and their ...

Company says the system empowers clinical teams to respond to surges, track usage and ease workflows with user-friendly touchscreen technology for telemetry patients on the move.

A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads. In 2018, the top causes of recalls were software, ...

Infographics can propel MedTech research and campaigns and enhance the user experience. Here Fabricio Pamplona, co-founder of online infographic maker for scientists Mind the Graph, explores the power ...

The application of AI in telehealth to allow doctors to make real-time, data-driven rich choices is a key component in generating a better patient experience and improved health outcomes. Artificial ...

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 ...

Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use. EU MDR required companies to make significant ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges.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 ...

A global need for less invasive medical procedures and high efficacy treatments has outlined the developments of cardiovascular devices. Cardiovascular diseases or CVDs have long been considered among ...