Transplant Biomedicals (Barcelona, Spain) said the first-in-human clinical trial of its kidney transportation device has yielded positive results. The 32-patient study of Vivian Kidney showed an “excellent safety profile” with no device-related adverse events and no organs being discarded before implantation, the company said. The device was also associated with a low rate of delayed […]
TransMedics slides on Q1 results
Newly public TransMedics (NSDQ:TMDX) shares traded down today after the medical device maker reported first-quarter results yesterday in its debut earnings release. TransMedics developed a transportation system for organ transplants that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. In April 2018 the company won pre-market approval from the FDA for […]
TransMedics wins expanded indication for donated lung preservation device
TransMedics (NSDQ:TMDX) said today that it won an expanded indication from the FDA for the transportation system for lung transplants it designed. In April 2018, Andover, Mass.-based TransMedics won pre-market approval from the FDA for its OCS Lung device for standard double-lung transplantation procedures; in Europe, the OCS Heart and OCS Lung devices are already on […]
5 ways medtech research aims to help veterans
As the United States prepares to honor its war dead on Memorial Day, medtech researchers are working to help survivors wounded in battle, both in body and mind. Whether the research comes out of government, industry or academia, there’s also a desire to help veterans facing other health challenges. The work is evolving. 3D printing […]
TransMedics reaps $105m in IPO
TransMedics (NSDQ:TMDX) yesterday closed an initial public offering that, including a fully subscribed over-allotment, grossed nearly $105 million. Andover, Mass.-based TransMedics developed a transportation system for organ transplants that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. A year ago it won pre-market approval from the FDA for its OCS Lung transplant device for […]
TransMedics prices IPO at $91m
TransMedics added more than $10 million to the previous top end for the initial public offering that’s slated to launch today, saying it now expects to raise $91 million. Andover, Mass.-based TransMedics developed a transportation system for organ transplants that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. A year ago […]
FDA clears Xvivo’s lung transplant perfusion system
The FDA today granted premarket approval to Xvivo Perfusion for its Xvivo Perfusion system with Steen solution perfusate intended to temporarily ventilate, oxygenate and pump preservation solution through lungs intended for transplantation procedures. The system is designed for use with lungs initially thought to be unacceptable for transplant, and allows a transplant team to perform […]
TransMedics sets IPO range with $75m midpoint
TransMedics yesterday set the range on its forthcoming initial public offering, which would gross more than $75 million at the midpoint. Andover, Mass.-based TransMedics developed a transportation system for organ transplants that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. A year ago TransMedics won pre-market approval from the FDA […]
TransMedics registers for $86m IPO
TransMedics last week registered for an initial public offering worth more than $86 million for the organ transplant transportation system it developed. The Organ Care System is designed to keep donated hearts, lungs and livers in near-living condition until transplantation; the company touts it as the only such system designed for more than one organ. […]
Is this the way to improve organ transportation?
Organ transplants are performed annually to remove diseased organs and replace them with healthy ones to extend the lifespan of patients. Potential transplant recipients are placed on a waiting list by a doctor who has determined that a transplant is the best course of action. Once a donor organ is available, the organ transportation system […]
FDA green-lights pediatric indication for Paragonix’s SherpaPak heart transport device
Paragonix Technologies said today that the FDA granted 510(k) clearance for a design change to its SherpaPak heart transport device so that it can be used with small and pediatric hearts. Braintree, Mass.-based Paragonix said it will begin shipping heart connectors covering most aortic diameters during the first quarter of 2019. “This FDA clearance is an […]
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