10 Principles for Machine Learning or AI Medical Devices from FDA

Although FDA has approved about 343 medical devices using Artificial Intelligence (AI) and Machine Learning (ML) technologies, a much larger number of devices using such technologies are used in general health awareness applications and do not require FDA’s review or approval for launch. These are mostly apps or software that collect data about real world … Read more

Covid Vaccines Stole the Limelight from Therapies, it Seems. 

Vaccines have overwhelmingly dominated the public and regulatory attention since the beginning of the pandemic. Most of the public funding and resources seems to have been devoted to developing effective vaccines rather than therapies. And it has worked, for the vaccines. While we have several vaccines for Covid and billions of people worldwide have been … Read more