Bayer Submits Low-Dose MRI Contrast Agent Gadoquatrane for Global Regulatory Approval
Bayer has submitted marketing authorization applications for gadoquatrane, an investigational MRI contrast agent that delivers 60% lower gadolinium dosing compared to standard agents while maintaining diagnostic efficacy.
FDA Expands Optison Ultrasound Enhancing Agent Approval for Pediatric Cardiac Imaging
The FDA has expanded approval for GE HealthCare's Optison, allowing the ultrasound enhancing agent to be used in pediatric patients with suboptimal echocardiograms, following successful Phase IV clinical trials.
GE HealthCare's Aurora SPECT/CT and Clarify DL Receive FDA Clearance, Advancing Nuclear Medicine Imaging
GE HealthCare has received FDA 510(k) clearance for its Aurora nuclear medicine system and Clarify DL, with University Hospitals in Cleveland becoming the first U.S. institution to adopt this technology.
Turing Medical Appoints Kevin King as CEO to Advance Brain Mapping Technology and Depression Treatment
Turing Medical has appointed Kevin King, former CEO of iRhythm Technologies, as its new President and Chief Executive Officer to accelerate the company's expansion in precision brain mapping technology.
FDA Clears J&J's AI-Enhanced Monarch Robot for Improved Lung Cancer Diagnosis
• Johnson & Johnson's Monarch Quest software update received FDA 510(k) clearance, boosting computational power by 260% to improve accuracy in reaching suspicious lung nodules. • The enhanced robotic platform integrates Nvidia's AI technology and GE Healthcare's OEC 3D mobile imaging system to navigate complex patient airways for more precise early-stage lung cancer diagnosis. • This advancement addresses a critical need in lung cancer detection, as nearly half of early-stage lesions occur in peripheral lung areas that are difficult to access with traditional bronchoscopy methods.
GE HealthCare Launches Flyrcado, Revolutionary PET Imaging Agent for Coronary Artery Disease
GE HealthCare has successfully administered the first doses of Flyrcado, an FDA-approved PET imaging agent for coronary artery disease detection, at Houston Methodist Hospital.
AI-Powered Breast Cancer Detection Gains FDA Clearance for Expanded Mammography System Compatibility
SmartMammo Dx, an AI algorithm by DeepHealth, secured FDA clearance for use with GE HealthCare's Senographe Pristina mammography systems.
Polarean Imaging Receives FDA Clearance to Expand MRI Chest Coil Compatibility
Polarean Imaging secured FDA 510k clearance for its MRI chest coil to include GE Healthcare's 3 Tesla MRI scanners, enhancing Xenon-129 nuclei visualization.
GE HealthCare's SIGNA MAGNUS Head-Only MRI System Receives FDA Clearance
GE HealthCare's SIGNA MAGNUS, a 3.0T head-only MRI, has received FDA clearance, offering advanced neuroimaging capabilities for clinical and research use.
GE HealthCare's Signa Magnus Head-Only MRI Scanner Receives FDA Clearance
GE HealthCare's Signa Magnus, a head-only MRI scanner, has received 510(k) clearance from the U.S. Food and Drug Administration, facilitating its market entry.