The company is pulling the new version of its transcatheter aortic valve off of shelves in Europe after it received some reports that the device could not be fully locked, which prevents the procedure from being completed. In each of the reported cases, the patients could be treated with a different valve.
Boston Scientific Corp. announced it is voluntarily removing field inventory of the Lotus Edge repositionable transcatheter aortic valve system, just weeks after launching it at select few European sites, after receiving reports that some of the devices could not be locked after deployment.
If the valve cannot be locked once it is in place in the aortic annulus, the procedure cannot be completed...
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Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.
