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With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions. Read More
Exactech has initiated a recall to remove Equinoxe shoulder system devices packaged in defective bags from facilities’ unused inventory the FDA announced in an update of its Jan. 16 safety communication on the products. Read More
The Department of Justice (DOJ), HHS and the FTC have jointly launched a public-facing portal for reporting unfair and anticompetitive practices that the Biden administration says will support its efforts to lower healthcare and prescription drug costs. Read More
The fact that China manufactures almost all of the active pharmaceutical ingredients (API) used to make drugs for Americans could be a threat to national security, according to FDA Commissioner Robert Califf. Read More
A second recall of Fresenius Kabi’s Ivenix Infusion System this year has been classified Class I by the FDA due to multiple potentially life-threatening anomalies caused by the device’s version 5.8.0 LVP software. Read More