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CardioQuip of College Station, Tex., has received a warning letter from the FDA for making changes to its cardiac heater-cooler without notifying or receiving permission from the FDA. Read More
Seattle, Wash.-based ocular damage treatment company LumiThera has completed its purchase of Diopsys, a developer of retinal disorder diagnostic devices. Read More
European device trade association MedTech Europe applauded the European Commission’s Feb. 23 publication of the Data Act, a broad-gauge regulation on data privacy, but it called on the commission to clarify the connections between the proposed legislation and existing device regulations. Read More
Various supply chain resilience measures are needed to ensure U.S. device production before the next pandemic or other natural disaster, a National Academy of Sciences, Engineering and Medicine (NASEM) expert panel advised in a new report. Read More