Global Device Approvals, Weekly Snapshot: Measuring 'Minimal Residual Disease' With NGS
Executive Summary
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the four added this week, Adaptive Biotechnologies gets FDA nod for a "minimal residual disease" next-gen sequencing platform in oncology, and more from Europe and Mexico.
You may also be interested in...
FDA Grants Blincyto Accelerated Approval Based On MRD Response Endpoint
Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.
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.