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 ...

Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial ...

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 ...

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 ...

For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control ...

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, ...

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 ...

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 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 ...

Wearables are changing the game for health monitoring. From smartwatches and rings to skin patches, glasses, and even bras, companies are in a race to bring the latest innovations to market. But as ...