Episode description
๐ฃ๏ธ We're excited to release the fifth installment of our MedTech Voices mini series about ๐๐ ๐๐๐ ๐๐ฑ๐ฉ๐๐ซ๐ญ ๐๐๐ง๐๐ฅ ๐
๐๐๐๐๐๐๐ค. If you've been following along, this series is all about sharing perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
๐๐ด ๐ต๐ฉ๐ฆ ๐ณ๐ฆ๐ฑ๐ฐ๐ณ๐ต ๐ฅ๐ช๐ด๐ค๐ถ๐ด๐ด๐ฆ๐ฅ ๐ช๐ฏ ๐ต๐ฉ๐ช๐ด ๐ค๐ญ๐ช๐ฑ ๐ด๐ฆ๐ฏ๐ฅ๐ช๐ฏ๐จ ๐ข ๐ฃ๐ข๐ฅ ๐ฎ๐ฆ๐ด๐ด๐ข๐จ๐ฆ ๐ต๐ฐ ๐ฎ๐ข๐ฏ๐ถ๐ง๐ข๐ค๐ต๐ถ๐ณ๐ฆ๐ณ๐ด? ๐ค
๐จโ๐ซย Jaishankar Kutty, Ph.D., VP of Intelligence and Innovation, is joined once more by Medical Director ๐ฉโ๐ซย Sally Sennitt. This clip focuses on a transcatheter heart valve โ likely a balloon-expandable valve โ and the report wasn't positive (even troubling). Our experts go into meaningful detail as to why.
Questions covered ๐
1๏ธโฃ What was your overall feeling about this one?
2๏ธโฃ What were some of your takeaways on the panel's comments and what was submitted to them?
3๏ธโฃ What does this mean for manufacturers?
We appreciate you listening!
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