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Aug. 28, 2012

Vol. 9 No. 169

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Experts: Early Collaboration With FDA Critical To Aligning Drug-Dx Approvals

Companies developing companion drugs and in vitro diagnostics (IVD) should hold joint meetings with CDRH and the Center for Drug Evaluation and Research (CDER) as early as possible and ensure that drug and diagnostic development timelines are aligned, Linda Burdette, director of regulatory affairs at Hoffmann-La Roche, said Aug. 21 at the Cambridge Health Institute’s Regulatory Compliance in Drug-Diagnostic Co-Development conference. Read More

EU Directive Requires Medical Device Recycling

The EU’s revised Waste Electrical and Electronic Equipment Directive includes new requirements for the recovery and recycling of medical devices. Read More

Wound Healing Device Set for Clinical Trial

Medical devices company Boston Scientific reported the receipt of CE Mark approval of an expanded indication for the Watchman left atrial appendage closure device, to help reduce stroke risk in patients with atrial fibrillation. Read More

Rights Group Demands Answers on the Use of Controversial Circumcision Tool

The KZN health department will have to explain why it’s still using the controversial male circumcision device Tara Klamp despite questions around its safety. Read More

Cook Medical to Open New U.S. Medical Device Manufacturing Plant in Illinois

At the opening of its newest U.S.-based manufacturing plant, Cook Medical President Kem Hawkins will discuss the impact reinvestment in small-town American cities such as Cook’s two plants in Canton, Ill., which have a combined investment cost of approximately $40 million, could have in reinvigorating America’s economy. Read More

Hollywog Receives FDA Clearance for Back Pain Device

Medical device company Hollywog has received two FDA 510(k) clearances to market its remote controlled devices for back pain. Read More

Trevo Retriever Effectively Removes Blood Clots in Patients With Stroke

Every 40 seconds, someone in the U.S. has a stroke, usually caused when a clot blocks an artery that supplies blood to the brain. Read More

Microflow, a Toaster-Sized Disease Detector, Will Get its First Test Run in Space

The Canadian Space Agency has announced the development of Microflow, a toaster-sized flow cytometer that could be used to diagnose diseases on long-term space missions. Read More