Approvals, stated exactly as they are.
No exaggeration, no shortcuts — every claim below is verifiable through the issuing authority.
Where PANCREASaver® stands today
Taiwan — TFDA License
PANCREASaver® is a Class II medical device software licensed by Taiwan's Food and Drug Administration (TFDA) under license number 衛部醫器製字第007946號. The license can be verified through the TFDA's public medical device database at www.fda.gov.tw ↗.
United States — FDA Breakthrough Device
PANCREASaver® received Breakthrough Device Designation from the U.S. FDA, recognizing its potential to provide more effective early detection of pancreatic cancer. A 510(k) submission was filed in July 2026 and is under FDA review. PANCREASaver® is not yet cleared for marketing in the United States. See the FDA Breakthrough Devices Program ↗.
Patents
The technology is protected by 10 invention patents — 4 in the United States and 6 in Taiwan — covering medical imaging analysis systems, machine-learning-based pancreatic lesion detection, and multi-stage reading architectures. See the full portfolio on the IP portfolio page ↗.
Clinical evidence
Performance is documented in 5 peer-reviewed publications, including Lancet Digital Health and Radiology, with 92.1% sensitivity for sub-2cm lesions, national multi-center AUC 0.95, and 92.8% specificity. Every figure carries a source — see the evidence center ↗.
What PANCREASaver® is — and is not
PANCREASaver® is an AI-based computer-aided detection (CADe) software intended to assist radiologists in identifying pancreatic lesions suspicious for pancreatic cancer on contrast-enhanced abdominal computed tomography (CT) images. It is a decision-support tool and does not replace the radiologist's judgment, the full clinical workup, or the standard of care.
- For use by qualified healthcare professionals only.
- AI findings must always be interpreted in the context of the complete clinical picture.
- Regulatory status and approved intended use vary by country; not all features are available in every market.
- This website is for education and product information; it does not constitute medical advice.
Regulatory questions, answered
PANCREASaver® has received FDA Breakthrough Device Designation. A 510(k) submission was filed in July 2026 and is under FDA review — the device is not yet cleared for marketing in the United States. In Taiwan, it holds TFDA license 衛部醫器製字第007946號.
Contrast-enhanced abdominal CT images, per the approved indications. The analysis is designed to fit into the existing CT reading workflow without changing acquisition protocols.
At leading Taiwan medical institutions including National Taiwan University Hospital, with 2,000+ cases interpreted to date (including clinical validation) and independent third-party validation performed.
No. PANCREASaver® is a decision-support tool that assists radiologists — it flags suspicious pancreatic lesions for closer review and never issues a diagnosis on its own.
Questions about regulatory status or clinical validation?
Our clinical team is happy to share verified documentation.