Global Device Approvals, Weekly Snapshot: PMA Drought Continues
Executive Summary
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A electrical stimulator for GI disease is among devices that made the list this week. Also, a drought in original PMAs and panel-track supplements in the US.
You may also be interested in...
Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down
Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here's an infographic to spotlight US device approval trends during the third quarter, July through September.
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.