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, ...

MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

Engaging a development partner early provides critical technical and regulatory insight to avoid costly redesigns and ...

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 ...

Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the ...

The beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the ...