The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation ...

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 ...

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 ...

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 ...

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 ...

The Service+Tech model embeds AI into the workflow of regulatory experts rather than treating technology as a standalone tool; an approach allowing organizations to adopt AI immediately, with no risk ...

Examines the increasing strain on caregivers in home-based care models, the level of support they need for various stages of care, and how improved technological devices and infrastructure can help ...

The future of healthcare lies in the successful integration of workflow automation and advanced technologies. As the buzz-word salad of AI, such as NLP, LLMs, Gen AI, RPA, etc continue to evolve, ...

As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is ...

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which ...