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The FDA details its expectations for postmarket surveillance of moderate and high-risk devices in two draft guidances, including its criteria for ordering postmarket data collection. Read More
Canadian hospitals reported almost 3,500 medical device incidents to Health Canada in 2020, the agency said in a progress report on mandatory reporting requirements introduced as part of the agency’s Medical Device Action Plan. Read More
In the face of increasing cybersecurity threats, the Biden administration is taking several measures to implement stronger cybersecurity standards, including requiring software developers to improve the security of the software supply chain. Read More
The pump, which is now cleared to treat acute right-heart failure for up to 14 days, includes sensors that allow remote monitoring from internet-connected devices. Read More
COBRA-OS is currently the smallest device on the market for use in endovascular balloon occlusion procedures, the London, Ontario-based company said. Read More
The robotic device is being marketed in the U.S. for spinal fusion procedures through the Austria-based firm’s partner company, Fusion Robotics. Read More