Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

For SLAS US 2023, we speak to Guy Starbuck, one of the co-founders at AIQ Global, about how we can utilize AI technology to bring new medical devices to market. Please could you introduce yourself and ...

Secure by design didn’t just pop up in the medical device industry with the update to the Food & Drug Administration (FDA) guidance on cybersecurity recommendations. However, its inclusion in this ...

U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...

Recent developments in 3D printing materials allow for better simulation of human anatomy, not only in shape but also in how tissues appear in medical imaging such as X-rays and CT scans. RadioMatrix, ...

Sure, you’ve heard it all before — how artificial intelligence (AI) is transforming design and development and the production process across the board, and that companies that don’t embrace the ...

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...

Nevada Sanchez, co-founder of Butterfly Network, talks to Machine Design about the organization making life-saving technology available to frontline healthcare workers in the developing world. In ...

It takes months of R&D, numerous prototypes, and a few scrapped concepts for the design of a device used in patient care to be finalized and approved. However, one aspect is often still missing at ...

Manufacturers can help reduce use error in the clinical setting by integrating good human factors practices and user-friendly design into their medical devices ...