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The programmer software can be updated either through an internet connection to the Medtronic Software Distribution Network or by a Medtronic representative plugging directly into the device. Read More
Canada’s Medical Technology Companies association said it strongly supports the Canadian government’s plans to change the country’s complex regulatory, reimbursement and procurement process for medtech. Read More
The agency revised the terms after the improper use of single-dose containers led to the transmission of bacterial and viral infections in multiple patients. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
Boston Scientific and Cook Medical questioned parts of the FDA’s guidance on premarket notifications for metal expandable biliary stents and their delivery systems — including limits on eligibility for the Special 510(k) program and some recommended test methods in the agency’s draft released in July. Read More