TransMedics Group WKN: A2PH5P ISIN: US89377M1099 Kürzel: TMDX Forum: Aktien Thema: Hauptdiskussion

TransMedics Receives FDA Approval for its OCS Heart System Enabling Broader Utilization of Donor Hearts for Transplantation in the U.S. https://finance.yahoo.com/news/transmedics-receives-fda-approval-ocs-110000048.html

Mmmh warum immer noch kein heart approval?!

TransMedics Reports Second Quarter 2021 Financial Results https://newsfilter.io/a/659c857080ad8af25445ce1ae96fad96 ...today reported financial results for the quarter ended June 30, 2021. Recent Highlights • Net revenue of $8.2 million in the second quarter of 2021, representing a 141% increase compared to the second quarter of 2020 • Announced positive FDA advisory committee vote for OCS Liver System • Received FDA 510(k) clearance of the OCS Lung Solution for use in lung transplants using cold storage techniques • OCS Liver PROTECT Trial results presented and recognized as the winner of The People's Choice Award for Most Impactful Presentation at the American Transplant Congress ...

TransMedics Receives FDA Clearance of OCS Lung Solution for Cold Preservation of Lungs https://finance.yahoo.com/news/transmedics-receives-fda-clearance-ocs-220500618.html TransMedics to Provide The Most Comprehensive Lung Preservation Product Portfolio to Lung Transplantation Centers in the U.S.

Die Richtung schaut schon mal gut aus: TransMedics Announces Positive FDA Advisory Committee Vote for the OCS Liver System https://www.finanzen.net/nachricht/aktien/transmedics-announces-positive-fda-advisory-committee-vote-for-the-ocs-liver-system-10333852 ...announced today that after review and discussion of TransMedics' clinical evidence from the OCS Liver PROTECT trial, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee convened by the U.S. Food and Drug Administration ("FDA") has issued a favorable vote in support of approval of the OCS Liver System.   The panel voted 14 to 0, that there is reasonable assurance that the OCS Liver System is effective and 14 to 0, that there is reasonable assurance of the OCS Liver System's safety. The panel voted 12 to 1, with 1 abstaining, that the benefits of the OCS Liver System outweigh its risks. ...

Panel Meeting heute, Trading halted

Nice hoffe bis dahin auf Zulassung von DBD

TransMedics Announces Scheduling of OCS Liver FDA Advisory Committee Meeting https://www.prnewswire.com/news-releases/transmedics-announces-scheduling-of-ocs-liver-fda-advisory-committee-meeting-301310185.html ...today announced that the U.S. Food and Drug Administration ("FDA") has announced the scheduling of a public advisory committee meeting during which it will review information regarding TransMedics' premarket approval application for the OCS Liver System. The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet on on July 14, 2021 to discuss, make recommendations, and vote on a recommendation for approval of the OCS Liver system.      ...

Dieses Jahr so viele gute News für das Unternehmen

https://www.prnewswire.com/news-releases/transmedics-announces-presentation-of-ocs-liver-protect-trial-results-and-is-recognized-as-winner-of-the-peoples-choice-award-for-most-impactful-presentation-at-the-american-transplant-congress-atc-2021-301308345.html

TransMedics Reports First Quarter 2021 Financial Results https://finance.yahoo.com/news/transmedics-reports-first-quarter-2021-200100167.html

Video zum Produkt....

https://youtu.be/GeLNkeaNM04

https://investors.transmedics.com/investor-relations/

FDA war ganz schön kritisch, noch ist es nicht 100% sicher. Kann glaube ich bis zu 60 Tage dauern bis finale Entscheidung getroffen wird.