Tag: FDA

Major Companies Selected In FDA’s Drug Tracking Block-Chain Pilot

Healthcare is one of the most important domains that determine the overall quality of the human resource of a given place. For every country in the world, it is of paramount importance that it has a healthy human resource base to plan for effective progress and to keep the economy growing. Without a stable health […]

FDA Prepares to Regulate AI in Medical Devices

New and advanced AI innovations are increasingly touching medical devices.  According to the Roll Call report, the FDA is already struggling with the reality of regulating all living things in a much better way. Looking forward, traditional ways of regulating medical devices are unlikely to work for the latest innovations powered by AI. At present, […]

AI under FDA Control?

On April 3, a Tuesday, the FA announced that it is building a new framework that would regulate AI-based medical devices, which learns continually from healthcare data and adapts. Scott Gottlieb, MD, FDA Commissioner announced his resignation last month and released a detailed discussion paper outlining the approach of the administration to pace up with […]

FDA Grants Clearance to AI-Powered Imaging System

Subtle Medical Inc., a California-based medical device company, has received clearance 510(k) from the U.S. Food and Drug Administration (FDA) to market its SubtlePET solution. SubtlePET is an Artificial Intelligence (AI)-powered advanced imaging system that allows the healthcare providers to improve image quality with the aid of Positron Emission Tomography (PET) scans. This would lead […]

Transparency and Change in the FDA Approval Process

FDA Transparency Initiative, which was launched back in the year 2009, has started achieving the desired results. The main goal of launching the initiative was to make the agency’s decision-making, procedures and actions more transparent and hence, more useful and comprehensible. In other words, it is aimed at disclosing FDA’s information in a controlled manner […]