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.

WASHINGTON—The federal government shutdown is delaying reviews and approvals of medical devices.

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.