Blue Earth Extends Global PET Reach With EU Approval
Executive Summary
Blue Earth Diagnostics, a molecular imaging agent specialist spun out of GE Healthcare, has secured EU approval to market its PET tracer for detecting recurrent prostate cancer. Axumin, which was approved in the US a year ago, is said to be only PET imaging agent for this indication in the EU.
You may also be interested in...
GE Spin-Off Wins US Approval For Prostate Cancer PET Tracer
Two years after being spun out of GE Healthcare’s PET imaging division, Blue Earth Diagnostics (BED) is poised to take its Axumin molecular imaging agent to the US prostate cancer market following FDA approval.
News We’re Watching: FDA Approves Medtronic's Affera, Roche's CGM Moves Closer To Approval, And More
Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.
New’s We’re Watching: J&J's Varipulse PFA Earns CE Mark; Labs Create Intravascular Robots; And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, Biosense Webster’s Varipulse PFA platform earned a CE mark; Biosense Webster also announced the start the pivotal IDE study of its Laminar left atrial appendage elimination system; the FDA approved Boston Scientific's Agent paclitaxel-coated balloon and cleared Medtronic's OsteoCool 2.0 bone ablation system; three papers in Science Robotics describe magnetically controlled vascular robots that could go places wires and catheters cannot.