More warnings on metal-on-metal hip implants in U.K, New Zealand | Regulatory Roundup
Edwards lands CE Mark for Intuity valve | Regulatory Roundup
Edwards Lifesciences Corp. (NYSE:EW) landed CE Mark approval in the European Union for its Intuity valve system.
The Intuity valve, made of bovine pericardial tissue, is a minimally invasive option for patients in need of aortic valve replacement.
Toshiba lands 510(k) for latest Aquilon CT scanner | Regulatory Roundup
Toshiba’s (TYO:6502) American medical products division won 510(k) clearance from the FDA for the latest iteration in its Aquilon line of CT scanners.
The Aquilon Prime is designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations with reduced radiation exposure, according to a press release.
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