- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
FDA Clears Emerging AI-Powered Software for Brain MRI
Leveraging AI technology, the AiMIFY software reportedly facilitates double the contrast enhancement in comparison to gadolinium-based contrast agents (GBCAs) for brain MRI.
Offering enhanced imaging capability for detection of lesions on brain magnetic resonance imaging (MRI), the artificial intelligence (AI)-enabled software AiMIFY has been granted clearance from the Food and Drug Administration (FDA) for a class II software as a medical device (SaMD).
Co-developed by Bracco Diagnostics and Subtle Medical, AiMIFY enhances contrast on brain MRI to a level that is double the contrast generated with labeled dosing of gadolinium-based contrast agents (GBCAs). The increased imaging clarity bolsters the detection of small lesions on brain MRI, according to the companies.
The recently FDA-cleared AI software AiMIFY reportedly enhances contrast on brain MRI to a level that is double the contrast generated with labeled dosing of gadolinium-based contrast agents (GBCAs). (Image courtesy of Adobe Stock.)
The companies emphasized research validation of aiMIFY use with a variety of vendor scanners and MRI sequences as well as datasets including diverse patient demographics and pathologies.
"By integrating Bracco's expertise in contrast imaging with Subtle Medical's cutting-edge deep-learning technology, we are poised to redefine diagnostic precision and efficiency, setting new standards in the field for the ultimate benefit of the patients,” noted Fulvio Renoldi Bracco, the vice chairman and CEO of Bracco Imaging.
FDA Grants Expanded 510(k) Clearance for Xenoview 3T MRI Chest Coil in GE HealthCare MRI Platforms
November 21st 2024Utilized in conjunction with hyperpolarized Xenon-129 for the assessment of lung ventilation, the chest coil can now be employed in the Signa Premier and Discovery MR750 3T MRI systems.
FDA Clears AI-Powered Ultrasound Software for Cardiac Amyloidosis Detection
November 20th 2024The AI-enabled EchoGo® Amyloidosis software for echocardiography has reportedly demonstrated an 84.5 percent sensitivity rate for diagnosing cardiac amyloidosis in heart failure patients 65 years of age and older.
