This expanded multi task FDA approval is a major high point for RHT , I wonder what this FDA approval will do for the share price and income it will generate from the USA alone ? RHT has a market cap of only $10.46 million , from today , this is a different ball game, Well Done.
The FDA 510(k) clearance for FerriSmart® is in addition to regulatory clearance obtained in July 2018 from the TGA - Therapeutic Goods Administration (Australia), and CE Mark (European Union) (ASX announcement dated 11 July 2018).
The FDA has cleared FerriSmart® with the following indications:
Measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;
Monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; and
Aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
RHT Price at posting:
2.6¢ Sentiment: None Disclosure: Held
