Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, ...

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to ...

The future of healthcare depends on cross-sector collaboration among regulatory, commercial, R&D, and business development teams. This integrated approach is crucial to avoiding siloed decisions that ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology 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 ...

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 ...

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 ...

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 ...

As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles. During the ...

An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR. When a nonconformance is identified, two things should be done ...

When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more ...