Interesting question. I have no answer, but there is an interesting Nuc Med case study from Australia that may help people form their own conclusions.Technegas is a Tc 99m labelledcarbon inhalation aerosol developed in Australia in 1984 and has been in widespread clinical use, including SPECT imaging, since 1986. Technegas is considered preferred in more than 60 countries for ventilation imaging yet has limited adoption in the United States. Indeed, in 1991 a Newsline article in The Journal ofNuclear Medicine posed the question, “When, if ever, will the device that has won near ubiquitous use in Australia gain approval for lung ventilation studies in the U.S.?
In 2021, SNMMI (globalPeak body for Nuclear Medicine) urged FDA to begin a fast-track review of theagent and in 2023 Technegas was approved to diagnose pulmonary embolism. “We applaud the FDA for the long-awaited approval of Technegas,” said SNMMI president.
An Australian company (Cyclopharm ASX:CYC) only took 40 years to get Technegas approved by the FDA. Is it because we are foreign?
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