OCS Heart for HCP's | 合法醫療器材資訊網
TheOCSHeartisunderFDAreviewforusewithutilizedandunutilizeddonorhearts.OCSHeartisaninvestigationaldeviceandis,therefore,limitedbyfederal ...
The only FDA approved technology for extracorporeal perfusion and preservation of donor hearts in the U.S.
The OCS Heart is a portable, warm perfusion, and monitoring system designed to keep a donor heart at a human-like, metabolically active state. By monitoring key parameters of the functioning heart, physicians may use their medical judgement to assess a potentially suitable heart’s condition and viability.
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Donor Heart Preserver Survives Review by FDA Advisors ... | 合法醫療器材資訊網
2021年4月7日 — The TransMedics Organ Care System (OCS) Heart System got closer to regulatory approval as it emerged victorious from a contentious FDA ... Read More
FDA advisory committee positive about TransMedics' OCS ... | 合法醫療器材資訊網
2021年4月8日 — FDA advisory committee positive about TransMedics' OCS Heart system ... TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory ... Read More
OCS Heart for HCP's | 合法醫療器材資訊網
The OCS Heart is under FDA review for use with utilized and unutilized donor hearts. OCS Heart is an investigational device and is, therefore, limited by federal ... Read More
Questions for the Advisory Committee meeting for the ... | 合法醫療器材資訊網
hearts accepted for OCS Heart perfusion in the EXPAND (including EXPAND CAP) and ... donor hearts (see Section 6.2.5 of the FDA Executive Summary). ... Please discuss whether the device, if approved, has demonstrated a reasonable ... The TransMedics® Orga Read More
TransMedics Announces Positive FDA Advisory ... | 合法醫療器材資訊網
2021年4月7日 — 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 ... Read More
TransMedics Announces Positive FDA Advisory Committee ... | 合法醫療器材資訊網
2021年4月6日 — If approved by the FDA, with the use of OCS Heart System for extended criteria donors, and DCD hearts, we can access to a significantly greater ... Read More
TransMedics Announces Scheduling of OCS Heart FDA ... | 合法醫療器材資訊網
2021年3月1日 — Some of the key factors that could cause actual results to differ include: the timing of and our ability to obtain and maintain regulatory approvals or ... Read More
TransMedics Announces Temporary Postponement of OCS ... | 合法醫療器材資訊網
2020年9月28日 — ... FDA has temporarily postponed the Advisory Committee meeting to review TransMedics' premarket approval application for its OCS Heart. Read More
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
2021年4月6日 — pressure. FDA does not believe that changes affected the poolability of the data ... CAP approved for up to 75 OCS-Heart perfused donor hearts. Read More
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