After some delay, the Government Accountability Office has drafted a report on FDA's 510(k) submissions program, which some expect will recommend reforms to the Class II, medium-risk category of devices
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Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.
Despite near-term cost pressures, Intuitive Surgical is expanding manufacturing and R&D in North America and Europe to meet demand for Ion, X and Xi systems.
