Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

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 ...

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech ...

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 ...

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 ...

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 ...

Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous. Literature ...

The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed interpretations of MDR and IVDR PMS ...

WALTHAM, Mass.–(BUSINESS WIRE)– Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced a definitive agreement to acquire Clario Holdings, Inc., a leading ...