The FDA is for the use of Oncosil in cholangiocarcinoma under a Humanitarian Device Exemption (or Humanitarian Device Use).
This exempts Oncosil from the usual requirements by the FDA and allows access (and payment) for use in uncommon conditions where the device is safe and may help in serious but rare conditions.
Cholangio fits that.
The use in cholangio has not been formally studied, except that the RCTs so far confirm it is safe to use.
The reason the approval is material to Oncosil is that once it has approval for CC, investigators will be able to apply for off label use in investigator led and other funded studies. It gets the tech into the USA hands and from there I think things will move quickly.
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