![]() ![]() Check with your local representative for availability in specific markets. Not all products are available in all regions. GDPR Statement | Declaration for California Compliance Law. Any person depicted in such photographs is a model. Photos displayed are for illustrative purposes only. Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy. The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. This website is governed by applicable U.S. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Bausch + Lomb acquires XIIDRA eye drops, delivery system from Novartis in $2.©2023 Abbott.The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions.When it comes to sales, medical device teams are capable of so much more. ![]() ReWalk Robotics, Myomo to benefit from new proposed Medicare classifications.Xtant Medical announces $15M private placement.Study backs Lunit’s AI-powered cancer diagnostics.Yesterday, Abbott said it won CE Mark approval in the European Union for its next-generation drug-eluting stent, the Xience Sierra.įiled Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Abbott ![]() The company said that in addition to the instrument clearance, it has also obtained clearance for several tests on the system with a “comprehensive menu of tests expected to be available within a year of launch,” according to a press release. With customer insights as our roadmap, the Alinity ci is engineered to simplify diagnostic testing while ensuring speed, accuracy and performance,” immunoassay and clinical chemistry R&D VP John Frels said in prepared remarks. We went beyond traditional market research and spent countless hours with our customers, listening to their challenges and observing how they work. “Alinity ci was designed using a different approach. customers as we work to gain approval for the full Alinity portfolio of instruments and assays,” Abbott diagnostic products exec VP Brian Blaser said in a prepared statement.Ībbott said its Alinity system includes the Alinity c clinical chemistry system and the Alinity i immunoassay system, both of which can operate individually or work together as an integrated Alinity ci-series unit. FDA clearance is a key first step in bringing this important innovation to our U.S. Labs and healthcare systems are looking for complete solutions that help them operate more efficiently while contributing to better clinical decision making and helping improve patient outcomes. “Healthcare systems across the United States are under pressure to deliver better care for patients. The newly launched ci-series of Alinity devices includes improvements such as smaller footprints, improved workflow capabilities and reduced wait times and simplified designs for error proofing and enhanced usability, the company said. Abbott (NYSE: ABT) said today it won FDA 510(k) clearance for its Alinity instruments for clinical chemistry and immunoassay diagnostics. ![]()
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