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

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

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

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

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

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

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

This article discusses why Colombia, despite the global effects of the COVID-19 pandemic, has become the country with the best commercial advantages in South America and one of the three best in Latin ...