The FDA designates Abbott’s (ABT +2%)
in-development Fully Implantable Left Ventricular Assist Device
(FILVAS) a Breakthrough Device for patients with advanced heart failure.
The designation, akin to Breakthrough Therapy
status for a drug, provides for more intensive guidance on development
from the FDA, the involvement of more senior agency personnel, the
assignment of a case manager, and priority review of the marketing
application.
https://seekingalpha.com/news/3537965-abbott-filvas-device-nabs-accelerated-review-in-u-s
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