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Device for open liver surgery gains FDA 510(k) clearance
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CAScination AG announced its surgical navigation system for open liver surgery, CAS-One LIVER, has been granted FDA 510(k) clearance, according to a press release.
The FDA 510(k) clearance allows the system, a surgical navigation system that uses ultrasound fusion technology for tumor removal without disrupting healthy parts of the liver, to be sold in the United States. The device enables surgeons to target small tumors and to identify structures at risk, leading to the treatment of advanced liver disease, according to the release.
“Our navigation solution has demonstrated its potential to enable new treatments for patients affected with liver cancer,” Matthias Peterhans, co-founder and chief executive officer of CAScination, said in the release. “We are pioneers in making navigation technology available for surgery on soft organs and believe that our products will lead to less invasive, more focused and less expensive management of the most relevant cancer diseases. Having attained FDA clearance, we are confident that CAS-ONE LIVER will become the new standard for effective liver cancer treatment.”
After being CE marked in 2010, the CAS-ONE LIVER device has been used in cancer centers across Europe.
Disclosure: Peterhans is an employee of CAScination AG.