An Australian-invented lung imaging agent has finally been cleared for use in America, decades after it became the standard of care in dozens of other countries.
ASX-listed Cyclopharm announced on Monday it had received Food and Drug Administration (FDA) approval for its Technegas product, a radiopharmaceutical that's been used to help diagnose or rule out pulmonary embolisms in 4.7 million patients in 64 countries since the 1980s.
Cyclopharm chief executive and managing director Dr James McBrayer told AAP that FDA approval would be transformational for the $265 million Sydney-based company.
