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.
Emerging AI Algorithm Shows Promise for Abbreviated Breast MRI in Multicenter Study
April 25th 2025An artificial intelligence algorithm for dynamic contrast-enhanced breast MRI offered a 93.9 percent AUC for breast cancer detection, and a 92.3 percent sensitivity in BI-RADS 3 cases, according to new research presented at the Society for Breast Imaging (SBI) conference.
Can Abbreviated Breast MRI Have an Impact in Assessing Post-Neoadjuvant Chemotherapy Response?
April 24th 2025New research presented at the Society for Breast Imaging (SBI) conference suggests that abbreviated MRI is comparable to full MRI in assessing pathologic complete response to neoadjuvant chemotherapy for breast cancer.
Clarius Mobile Health Unveils Anterior Knee Feature for Handheld Ultrasound
April 23rd 2025The T-Mode Anterior Knee feature reportedly offers a combination of automated segmentation and real-time conversion of grayscale ultrasound images into color-coded visuals that bolster understanding for novice ultrasound users.
