Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies,.
Definition of SaMD Software as a Medical Device FDA has approved 500 algorithms employing AI SaMD, developing or licensing a new SaMD who ownes the IP with AI and machine learning, what is a regulated medical device under the FDA SaMD, FDA cybersecurity concerns and SaMD patient privacy