What happened
EndoSure announced CE marking for commercial use in the European Union. The 30-minute test uses abdominal sensor pads to measure gastrointestinal myoelectrical activity, then applies a decision tool intended to support an endometriosis diagnosis. A CE mark establishes market conformity in Europe; it is not FDA approval and it does not by itself prove real-world diagnostic performance. EndoSure’s own site states that the test is available only for research use in the United States, not clinical use.
Why it matters
A reliable non-invasive test could shorten the long path from symptoms to diagnosis and reduce reliance on surgery in appropriate cases. But regulatory market access and clinical endorsement are different thresholds. The Royal College of Obstetricians and Gynaecologists said in July 2026 that EndoSure’s strongest accuracy claims came mainly from small developer-led studies and considered the test experimental pending stronger independent evidence.
What to watch
Results from the NHS-sponsored ADDEND diagnostic-accuracy pilot, final NICE guidance, independent peer-reviewed validation in diverse primary-care populations, false-positive and false-negative rates, and whether a result leads to faster appropriate care without unnecessary procedures.
