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San Francisco, Calif-based prescription digital therapeutics company Blue Note Therapeutics has teamed up with clinical trial administrator Curebase for a “virtual” clinical trial to reach patients with cancer-related distress. Read More
Once a root cause analysis is complete, the next step is to develop a corrective and protective action (CAPA) plan. The plan should begin with a clear statement of the problem as identified by the analysis, describing in detail in what process, procedure or product the problem was found. Read More
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
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The FDA should consider broadening the scope of its draft guidance, “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology,” device manufacturers said in written comments to the agency on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