In medical device development, things don’t go quite as you planned the first time around. This article shares what to really ...

As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are ...

Neuromodulation devices are used to manage conditions such as chronic pain, neurological disorders, epilepsy, and more. New ...

Qualification, and demonstration of fit-for-purpose, for a drug product vial/stopper/seal primary package system comprises many factors: protection, compatibility, safety, and performance. One of the ...

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 ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

The Patent Office has extensively and thoughtfully analyzed legal precedents it is required to follow and attempted to harmonize and synopsize those precedents. 3 Its guidance sets forth complicated ...

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, ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...