Antimicrobial Susceptibility Test-Makers Seek Ways To Shorten FDA Clearance Process
A group of antimicrobial susceptibility test manufacturers are working with US FDA regulators to hasten the clearance process for their products. The agency recent convened a workshop at its Maryland headquarters to help address the issue.
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Stefan Willemsen, a top executive at diagnostics firm bioMérieux, has been working through AdvaMedDx with FDA, and with US House members to signal industry support for a bill to create a separate diagnostic regulatory framework at FDA. He spoke about that effort and explained how his firm’s products can be helpful in pinpointing cases of antibiotic resistance.
Market Intel: From AI-Based IVDs To Precision Drug Dosing: Medtech Conference 2017 Gives Insight Into Tomorrow's Technologies
The annual AdvaMed conference, rebranded "Medtech Conference" this year, drew more than 2,700 attendees seeking to explore cutting-edge technologies and networking opportunities, as well as to hear from FDA's top officials about new developments. This article takes a closer look at some of the most innovative solutions presented at the event, including machine learning-based diagnostics to combat antimicrobial resistance, a ureter-locating device, virtual reality technologies to enhance orthopedic surgery and precision drug dosing, among other things.
The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.