FDA Clears Syringe-less Injector for MRI Contrast Media
The Max 3 syringe-less injector reportedly offers improved efficiency and intuitive features with contrast media use for magnetic resonance imaging.
The Food and Drug Administration has granted 510(k) clearance for the Max 3™ contrast media injector for use in magnetic resonance imaging (MRI) exams.
Offering ease of use features to foster workflow efficiencies, the Max 3 is a syringe-less injector, according to Bracco Diagnostics, the manufacturer of the modality, which was developed in collaboration with Ulrich Medical.
The syringe-less contrast media injector Max 3 garnered 510(k) clearance from the Food and Drug Administration (FDA) for use in magnetic resonance imaging (MRI) exams. (Image courtesy of Bracco Diagnostics.)
Emphasizing direct injection from original contrast media vials, Bracco Diagnostics highlighted the Max 3’s combination of the Easy-Click Cassette flex and SafeConnect. The company noted these features enable dedicated connection to patient tubing with protection from retrograde contamination. The connector with the Easy-Click Cassette can be utilized within a 24-hour period or up to a maximum of 96 bottles of contrast media, whichever occurs first, according to Bracco Diagnostics.
The company pointed out that the lack of power cables with Max 3 enable convenient positioning of the device within the MRI room. In addition to eliminating the need to refill syringes, Bracco Diagnostics said use of the Max 3 reduces disposable plastic waste.
"We're thrilled to bring an intuitive, easy-to-use, and environmentally friendly solution to the radiology community in collaboration with Bracco," said Klaus Kiesel, the chief executive officer of Ulrich Medical. "Together, we're taking MRI innovation to the next level in health care."
Meta-Analysis Shows No Difference Between bpMRI and mpMRI in Ruling Out csPCa
March 6th 2025In an 18-study meta-analysis involving over 4,600 patients, researchers found that bpMRI and mpMRI had equivalent pooled negative predictive value (NPV) of 92 percent for clinically significant prostate cancer (csPCa).
Is MRI Contrast Enhancement Necessary for Long-Term Monitoring of Diffuse Glioma?
March 4th 2025In a comparison of contrast-enhanced T1-weighted (CET1w) MRI (and T2-weighted MRI/FLAIR imaging, researchers found that only three out of 82 cases of glioma progression were solely detected with CET1w MRI.
Can Deep Learning Ultra-Fast bpMRI Have an Impact in Prostate Cancer Imaging?
March 3rd 2025A deep learning-enhanced ultra-fast bpMRI protocol offered similar sensitivity for csPCa as mpMRI with an 80 percent reduction in scan time, according to research findings presented at the European Congress of Radiology (ECR) conference.
