This website requires certain cookies to work and uses other cookies to help you have the best experience. By visiting this website, certain cookies have already been set, which you may delete and block. By closing this message or continuing to use our site, you agree to the use of cookies. Visit our updated privacy and cookie policy to learn more.
This Website Uses Cookies By closing this message or continuing to use our site, you agree to our cookie policy. Learn MoreThis website requires certain cookies to work and uses other cookies to help you have the best experience. By visiting this website, certain cookies have already been set, which you may delete and block. By closing this message or continuing to use our site, you agree to the use of cookies. Visit our updated privacy and cookie policy to learn more.
WASHINGTON—The U.S. Food & Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency have jointly identified 10 guiding principles that can help manufacturers build safe, effective and high-quality medical devices that enable artificial intelligence and machine learning.
WASHINGTON—In conjunction with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, the U.S. Food and Drug Administration has published 10 guiding principles for Good Machine Learning Practice in the development of medical devices.
ROCK HILL, SC–The FDA has provided 510(k) clearance for a patient-specific, 3D-printed instrument set used during ankle replacement surgery with Exactech’s Vantage Total Ankle System.
IRVINE, CA — BIOLASE Inc. announced that it expects to partner with MEKICS Co. Ltd, an intensive care unit (ICU) equipment manufacturer, to supply ICU-grade portable ventilator through BIOLASE's FDA-registered manufacturing facility in California.
NEWARK, NJ—The FDA has ordered a manufacturer of dental implants to stop production after finding numerous quality control violations at the company’s assembly plant here.