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Biophan Technologies, a developer of products that enhance device safety and compatibility with magnetic resonance imaging (MRI), signed an exclusive agreement for its technology solution to be used with Boston Scientific’s vascular implant, MRI visible stent, vena cava filter and heart valve technologies.
A proposal by the Bush administration to cut Medicare payments for home oxygen tank equipment in the hope of saving the government billions of dollars would affect more than 1 million seniors who rely on the tanks every day.
While the current electronic common technical document (eCTD) holds "a ton of value" for FDA-regulated life science companies, leveraging the Health Level Seven (HL7) standards can vastly improve eCTD benefits, said Ken VanLuvanee, president and CEO of Apyx.
Protecting your computer system and edata center against damaging viruses often requires a quick application of available "patches," argues a new white paper.
Success in moving investigational new drug (IND) projects toward adopting the electronic common technical document (eCTD) is more about collaboration than technology, experts said at a recent industry gathering.
Authoring standards can minimize problems and unexpected glitches such as inconsistent document formats, cost overruns and staff burnout when putting together electronic submissions, experts said last month at a Drug Information Association (DIA) conference.
While drug and device firms know they need to manage their intellectual property electronically, they also face ongoing business and operational challenges around regulatory, quality and project management needs, according to an expert.