Practice
Breast biopsy needle shortage now extends into 2027
FDA now expects stereotactic breast biopsy needle supply disruption to continue through March 2027 and is advising providers to conserve available devices.
Company
U.S. Food and Drug Administration
Clinical
Ambelvist adds lower-dose GBCA option for MRI
FDA approval covers gadoquatrane for detecting and visualizing lesions with abnormal vascularity in CNS and non-CNS body regions across adult and pediatric patients.
Practice
GE Allia recall centers on service electrical-shock risk
FDA records list 5 Class 2 recalls for GE HealthCare Allia angiographic X-ray systems equipped with Gaia generators and affected electrical cabling.
Clinical
Stanford delivers first S250-FIT proton treatment
Mevion said the treatment was delivered inside an existing conventional radiation therapy vault using its S250-FIT system with Leo Cancer Care’s Marie platform.
AI & Imaging
GEHC clearance adds PCCP route for contouring AI
MIM Contour ProtégéAI+ 2.0 adds MR brain and updated CT male pelvis models, with an FDA-cleared change plan for future model updates.
AI & Imaging
Clarius Ejection Fraction AI gains FDA clearance
The software is integrated into the Clarius Ultrasound App and is intended for semi-automatic LVEF measurement in adult patients using compatible Clarius scanners.
AI & Imaging
Elastography anchors Mindray Hepatus GI ultrasound line
Mindray’s expanded Hepatus-Series pairs Visualized Transient Elastography with diagnostic ultrasound across a full gastroenterology platform and a focused liver-scanning system.
AI & Imaging
Pulmera CBeam gains FDA clearance for intraoperative 3D imaging
Pulmera’s platform attaches to conventional 2D surgical C-arms and reconstructs rotational X-ray images into 3D datasets for intraoperative visualization.
Business
Telix, United Imaging explore U.S. theranostics research
Telix and United Imaging Healthcare North America will evaluate a U.S. research collaboration focused on scanner, software, AI, and radiopharmaceutical workflow integration.
AI & Imaging
Philips Elevate Plus gains FDA clearance for ultrasound AI
Elevate Plus for EPIQ Elite and Affiniti includes Auto Measure Abdomen, Koios decision-support integration, and image-quality tools for general imaging ultrasound.
Practice
FDA cites ZOLL over MRI ventilator labeling gaps
The agency said ZOLL did not adequately validate labeling for 731 Series MRI-compatible ventilators intended for use with 1.5T and 3T MRI scanners.
Business
uMI Panvivo Mobile joins United Imaging PET lineup
United Imaging used SNMMI 2026 to show new PET/CT and PET/MR systems, including uMI Panvivo Mobile, uMI Panorama GS, and uPMR Zenith.
AI & Imaging
MIM KineticID awaits FDA review for dynamic PET
GE HealthCare said the kinetic-modeling software is designed for 4D visualization, Patlak analysis, curve fitting, and tracer-behavior assessment across PET systems.