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.

The Food and Drug Administration is changing the most common way it approves new low- to moderate-risk medical devices for use in the United States.

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.