Elutia submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its next-generation drug-eluting biomatrix product, CanGarooRM. Tailored for use with cardiac implantable electronic devices, such as pacemakers and internal defibrillators, CanGarooRM addresses a $600 million market, currently served by only one competitor. The decision to file came after the Company received feedback from a pre-submission meeting with the FDA. The Company anticipates an approval decision in the first half of 2024 and is now preparing for commercial launch.
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