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A majority of “smart” infusion pumps are vulnerable to hacking, in many cases because of software flaws that have long been known, according to a report by Palo Alto Networks, a Santa Clara, Calif.-based cybersecurity company. Read More
The FDA has issued a warning letter to Wickimed Medical Equipment Manufacturing for violations of good manufacturing practices (GMP) in making its sterile single-use disposable electrodes. 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
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
The FDA should consider broadening the scope of its draft guidance, “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology,” device manufacturers said in written comments to the agency on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
The FDA should go ahead with its plans to overhaul its Quality System Regulation (QSR) to harmonize it with the International Organization for Standardization’s ISO 13485 standard, but should give device manufacturers more than one year to implement the revised regulation, industry speakers said at a meeting of the agency’s Device Good Manufacturing Practice Advisory Committee on Wednesday. Read More
To clarify the FDA’s recommendations on quickly and effectively removing potentially harmful drugs and devices from the market, the agency has published a final guidance focused on recall readiness. Read More
The FDA has extended its review period for AbbVie’s and Boehringer Ingelheim’s Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe Crohn's disease in patients age 16 years and older, calling for details of the injector device. Read More
If a device sponsor wishes to appeal a rejection from the FDA’s Center for Devices and Radiological Health (CDRH), it should follow the chain of command to the next level up from the official who made the decision, the agency said in a final guidance released yesterday. Read More
The Friends of Cancer Research (FOCR) is urging the FDA to better coordinate simultaneous approval of new cancer drugs and companion diagnostics, and to focus on more speedy approval of diagnostics for rare cancer biomarkers. Read More