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In March 2020, the company announced a rapid diagnostic test for SARS-CoV-2; the U.S. FDA granted an emergency use authorization for the test. [19] The diagnostic is designed to run on any of the (over 23,000) existing Cepheid GeneXpert machines worldwide, with the standard 45 minute detection time.
In November 2020, Hologic won a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, Wisconsin, Maine, and California, with the goal to provide 13 million COVID tests per month by January 2022. [14] [15]
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
Its Biopharma Laboratory Services segment provides drug development, medical device and diagnostic development services to pharmaceutical, biotechnology, medical device, and diagnostic companies. [1] In 2023, this division provided support to 84% of the new drugs and therapeutic products approved by the Food and Drug Administration. [1]
NuVasive, Inc. is a medical devices company based in San Diego, California. Founded in 1997, it primarily develops medical devices and procedures for minimally invasive spine surgery. NuVasive's products include software systems for surgical planning and monitoring, access instruments, and implantable hardware.
Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. [4]
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