Global Device Approvals, Weekly Snapshot: Pelvic Floor Strengthener, Peripheral Stent
Executive Summary
A snapshot of medical device approvals captured in Medtech Insight's Approvals Tracker. A muscle stimulation device to treat urinary incontinence passed US FDA's review, while a peripheral artery stent with a new delivery system gained European sign off.
You may also be interested in...
Innovo Incontinence Device Goes OTC In US, Labeled To Be Worn For 30 Minutes
Atlantic Therapeutics estimates that one in three women are incontinent, but 60% don’t ask their health care providers about treatment, a statistic that supports offering Innovo OTC less than two years after it launched Rx in the US.
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.