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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
Mountain View, Calif.-based Crosscope has teamed up with Germany’s Mindpeak to develop new digital tools designed to improve cancer diagnosis. Read More
The FDA should consider broadening the scope of its draft guidance, “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology,” device manufacturers said in written comments to the agency on the draft, which was released for comment on Dec. 23, 2021. Read More
So far, the FDA says, it has not received reports of injuries, adverse health consequences or deaths associated with use of ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test. Read More