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Home » Keywords » Alung Technologies Inc.

Items Tagged with 'Alung Technologies Inc.'

ARTICLES

Alung’s de novo for extracorporeal carbon dioxide removal requires extensive in vivo testing

Jan. 3, 2023
By Mark McCarty
The U.S. FDA has released the special controls needed for extracorporeal carbon dioxide removal thanks to the successful pursuit of a de novo petition by Pittsburgh-based Alung Technologies Inc., but generating the clinical data for successor 510(k) devices will be no mean feat. While some of the associated in vivo testing may be performed on animal models, the list is extensive and includes testing for hemodynamic instability and inadequate gas exchange, all reasons that Alung and the FDA needed the better part of a decade to bring this device to the U.S. market.
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Doctor, patient using Hemolung

Hemolung respiratory assist system gets de novo nod

Nov. 15, 2021
By Annette Boyle
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
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Alung-hemolung-system.png

FDA OKs emergency use of Alung’s Hemolung for COVID-19 patients

April 24, 2020
By Meg Bryant
Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.
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