SCIENTIFIC CONFIDENCE INDEX — 45/100
Direct verification required for access information in Türkiye
Brief conclusion: Histotripsy is a nonthermal ultrasound ablation used in selected liver tumors. As of October 2026, we could not verify a comprehensive and official list of centers in Türkiye with an active Edison histotripsy system. This does not mean that the device is definitely unavailable in Türkiye.
Is it available in Türkiye?
International patient information pages about histotripsy published by hospitals do not prove that the device is installed in Türkiye. The center’s device model, installation location, active procedure capacity, and practitioner team must be directly verified.
Licensing and reimbursement
The US FDA granted De Novo authorization to the Edison system on October 6, 2023; 510(k) decisions were recorded in 2024. The FDA decision does not provide automatic TİTCK/ÜTS registration or SGK reimbursement in Türkiye. Since current ÜTS registration, SUT code, and payment coverage could not be definitively verified in this research, no definitive claim can be made for Türkiye that it is licensed, unlicensed, or covered by SGK.
Patient selection
Selected patients with primary liver cancer and liver metastases may be evaluated. Tumor size, number, anatomical location, proximity to blood vessels and bile ducts, liver reserve, other foci of disease, and standard treatment options are important.
Clinical conditions
A multidisciplinary tumor board including hepatobiliary surgery, interventional radiology, and medical oncology; contrast-enhanced MRI/CT, liver function tests, coagulation assessment, ultrasonic target visibility, and acoustic window check are required. Operator training, anesthesia, complication management, and a post-procedure contrast-enhanced imaging protocol must be in place.
Procedure and follow-up
The target lesion is planned with ultrasound; focused pulses create tissue destruction through controlled cavitation. The need for sedation/anesthesia and hospitalization may vary depending on the patient and the center. Follow-up imaging is mandatory for the detection of residual viable tumor.
Questions to ask the center
Is there an active device? What is its model and indication for use? How many procedures has the team performed? How is its ÜTS/TİTCK status documented? Does SGK or private insurance pay for it? What is the complication management and follow-up plan?
International access
If access cannot be verified in Türkiye, the manufacturer’s current center network and practicing hospitals should be contacted directly. Price, insurance, visa, and medical eligibility should be evaluated separately.
What do we not know?
The complete list of active centers in Türkiye, local procedure numbers, current device registration, price, and reimbursement status require independent verification.
Scientific background
Histotripsy literature review.
References
FDA De Novo; FDA 510(k); International patient guide.
This article is not a personal treatment recommendation. Administrative and clinical conditions in Türkiye may change.
