FDA advisory committee positive about TransMedics' OCS ... | 合法醫療器材資訊網
2021年4月8日—FDAadvisorycommitteepositiveaboutTransMedics'OCSHeartsystem...TransMedics(NSDQ:TMDX)thisweeksaidthattheFDACirculatory ...
TransMedics[1] (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System.
The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable assurance that the OCS Heart System is effective. It also voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System’s safety.
“This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S. We are looking forward to working collaboratively with the FDA as it completes its review,” president and CEO Waleed Hassanein said in a news release[2].
“We are now laser-focused and looking forward to our next ...
Donor Heart Preserver Survives Review by FDA Advisors ... | 合法醫療器材資訊網
FDA advisory committee positive about TransMedics' OCS ... | 合法醫療器材資訊網
OCS Heart for HCP's | 合法醫療器材資訊網
Questions for the Advisory Committee meeting for the ... | 合法醫療器材資訊網
TransMedics Announces Positive FDA Advisory ... | 合法醫療器材資訊網
TransMedics Announces Positive FDA Advisory Committee ... | 合法醫療器材資訊網
TransMedics Announces Scheduling of OCS Heart FDA ... | 合法醫療器材資訊網
TransMedics Announces Temporary Postponement of OCS ... | 合法醫療器材資訊網
TransMedics' 'heart in a box' donor organ preservation system ... | 合法醫療器材資訊網
TransMedics® Organ Care System™ (OCS) Heart System | 合法醫療器材資訊網
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