Regulatory status, stated precisely.
Every statement below should be checked against the issuing authority or cited publication.
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, as described in the FDA program and designation documentation. FDA Pending; PANCREASaver® is not yet cleared for U.S. marketing. 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 6 peer-reviewed publications, including Lancet Digital Health and Radiology, with 92.1% sensitivity for sub-2 cm lesions, national multicenter AUC 0.95, and 92.8% specificity. Every figure carries a source — see the evidence center ↗.
What PANCREASaver® is designed to do
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 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 FDA Breakthrough Device Designation. FDA Pending; the device is not yet cleared for U.S. marketing. In Taiwan, it holds TFDA license 衛部醫器製字第007946號.
Contrast-enhanced abdominal CT images, per the authorized indications. The analysis is designed to fit into the existing CT reading workflow without changing acquisition protocols.
Across Taiwan medical centers, regional hospitals, and accredited health checkup centers. As of October 13, 2026, PanCAD.ai reports that PANCREASaver® has been used in more than 5,500 patient cases across research and commercial applications. See the cited documentation for deployment and validation scope.
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.