Arch Therapeutics Targets mid-2016 For Commercial Launch Of AC5 Hemostatic Agent
This article was originally published in Clinica
Executive Summary
Arch Therapeutics has begun enrolling a 46-patient randomized trial to support a CE mark for its AC5 topical hemostatic agent by sometime in the summer, Arch Therapeutics president and CEO Terence Norchi told Clinica.
You may also be interested in...
Arch Therapeutics Closes In On CE Mark For Novel Blood Control Agent
Securing the CE mark for its topical hemostatic agent has taken Arch Therapeutics longer than expected, but the company now predicts filing for a CE mark by the end of 2016, and is looking for a partner to help commercialize it in Europe.
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.