The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Lets take a closer ...

The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies ...

Openwater CEO Aaron Timm shares how open source can reduce the cost of technology and extend its reach to more hospitals, ...

Structural heart innovation demands thinner, stronger materials and scalable manufacturing. Read how material expertise and ...

PET heat shrink is a strong barrier for medical devices, but difficult to remove. Peelable polyester heat shrink tubing is ...

Disc pumps enable quieter, smaller, and more precise wearable medical devices, improving patient comfort, measurement accuracy, and system reliability for innovative healthcare solutions.

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...