'''''Bayer announced that Ultravist (iopromide)-300, -370, its iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography(CEM) – making it the only contrast agent approved for this ...'

'''''Keya Medical has launched the DeepVessel FFR, a software device that utilizes deep learning to facilitate fractional flow reserve (FFR) assessment based on coronary computed tomography angiography (CCTA). Cleared by the Food and Drug Administration ...'

'''''The U.S. Food and Drug Administration (FDA) Sept. 30 cleared the world's first photon-counting computed tomography (CT) scanner, the Siemens Naeotom Alpha. Both the FDA and CT experts say this is the start of a revolution in new CT scanner technology, ...'

'''''Hologic, Inc., an innovative medical technology company primarily focused on improving women's health, announced U.S. Food and Drug Administration (FDA) clearance and commercial availability of the Company's Genius AI Detection technology, a new deep ...'

'''''RadioMedix Inc. and its commercial partner Curium announced today that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA). Copper Cu 64 dotatate injection is a PET diagnostic agent ...'

'''''Canon Medical Systems USA Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance on its Advanced Intelligent Clear-IQ Engine (AiCE) for the Aquilion Precision computed tomography (CT) system. The clearance further expands access to ...'

'''''Bracco Diagnostics Inc. announced U.S. Food and Drug Administration (FDA) approval for Varibar Thin Liquid (barium sulfate) for oral suspension, which is indicated for modified barium swallow (MBS) studies. The contrast agent is used to detect and ...'

'''''Royal Philips today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its innovative AlluraClarity live image guidance system in the US. In close collaboration with leading clinicians in the field ...'

'''''Royal Philips Electronics NV (PHIA.AE) has received a U.S. Food and Drug Administration warning letter citing several issues the agency found during an inspection of a Cleveland facility where Philips makes computed tomography and nuclear medicine ...'

'''''Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design and planned analysis of a ...'