Tag: FDA

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 […]