Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from ...

To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...

A device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: The electronic transfer of medical ...

Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure ...

ATLANTA, March 7, 2014 /PRNewswire/ -- If you are a Southeastern Medical Device or Medical Device Data System (MDDS) company seeking growth capital, the MARCH 10 th APPLICATION DEADLINE to present at ...

The FDA signaled a shift from regulatory discretion to enforcement discretion regarding Medical Device Data Systems (MDDS) with the publishing of the final rule on February 14, 2011. Ostensibly, the ...