Caner Turay, Marketing Director at OncoSil Medical, shared OncoSil Medical’s post on LinkedIn, adding:
“A very important milestone
The FDA HDE approval of the OncoSil device for the treatment of distal cholangiocarcinoma (dCCA) in the U.S. marks a significant step forward and an important new chapter for OncoSil Medical.
Reaching this point reflects many years of work, commitment and persistence from everyone involved.
It’s great to see this milestone achieved and to know that OncoSil can now move forward in the U.S., with the potential to make a meaningful difference for patients with dCCA.”
Quoting OncoSil Medical’s post:
“A major milestone for OncoSil Medical!
We are pleased to announce that the U.S. FDA has granted Humanitarian Device Exemption (HDE) approval for the OncoSil device for the treatment of distal cholangiocarcinoma (dCCA) in the United States.
This represents the most significant regulatory milestone in OncoSil Medical’s history and provides U.S. marketing authorisation for OncoSil under the HDE framework. We sincerely thank everyone who has contributed to this achievement over the years.
This marks the beginning of an important new chapter for OncoSil Medical as we work to make a meaningful difference for patients facing this challenging cancer.
Click here to read the full announcement.”
You can also read: FDA Grants HDE Approval to OncoSil for Distal Cholangiocarcinoma
