PMA supplement is submitted to FDA covering use of the AutoPap automated primary Pap smear slide screening system with cytology samples prepared using the Prep automated, liquid-based Pap smear sample preparation system. TriPath is the new name for the recent combination of Prep system developer AutoCyte and AutoPap maker NeoPath under a June merger completed Oct. 1 (1"The Gray Sheet" June 14, p. 15). The Prep system was approved June 17 to replace conventional Pap smear preparation in primary screening for cervical cancer but not specifically for use with AutoPap, which was approved for initial screening of conventional slides in May 1998
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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.
