{"article":{"annotation":{"article_id":"anx-proscan-fda-reading-times","available_at":"2026-10-11T21:35:43.788388Z","geography_revision":"ef6ee0010dda5fe7b240fd514749b43e214c57da73222d2e40ec83b276dd0977","id":"c3613133f73728a432d3c07be7cbb8dc1208d4496af464902686cd5893e7c9ad","input_sha256":"f06f7caaab145d68248a394b406a961eda41d3978f8d14d0a0a2749bfb25c286","limitations":["Rule-derived subjects are candidates, not verified editorial labels or calibrated model probabilities.","Coverage is distinct from event location. Unknown country/city/coordinates remain absent; no automatic geocoding.","Article geometries keep their stated precision and methodology; reproducing them is not independent coordinate verification."],"method":"controlled-rules-v1","places":[{"admin1":null,"city":null,"coordinate_note":null,"coordinate_reference_system":"OGC:CRS84","coordinate_source":null,"country":"US","evidence":[{"field":"country","language":"en","note":"Explicit preserved editorial country/region; no city or national centroid inferred","source_urls":["https://www.prnewswire.com/news-releases/anx-robotica-highlights-documented-proscan-ai-workflow-performance-from-submission-to-fda-302905102.html","https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230027.pdf","https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254230.pdf"]}],"geometry":null,"id":"iso3166-1:US","kind":"country-or-area","labels":{"ar":"الولايات المتحدة الأمريكية","en":"United States of America","es":"Estados Unidos de América","fr":"États-Unis d’Amérique"},"match_status":"candidate","precision":"regional","role":"coverage","uncertainty_m":null}],"rules_sha256":"fb5ad3c27c91cb840f7a0a05f7f64a5cb26ad0374409ff9457f277c7092e22b4","schema_version":1,"subjects":[{"concept_id":"medtop:20001298","confidence":null,"confidence_method":null,"evidence":[{"field":"en.title+en.summary","language":"en","note":"Subject suggested from the title or summary: AI","source_urls":["https://www.prnewswire.com/news-releases/anx-robotica-highlights-documented-proscan-ai-workflow-performance-from-submission-to-fda-302905102.html","https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230027.pdf","https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254230.pdf"]}],"method":"controlled-rules-v1","rule_id":"artificial-intelligence","status":"candidate"},{"concept_id":"medtop:20000225","confidence":null,"confidence_method":null,"evidence":[{"field":"en.title+en.summary","language":"en","note":"Subject suggested from the title or summary: software","source_urls":["https://www.prnewswire.com/news-releases/anx-robotica-highlights-documented-proscan-ai-workflow-performance-from-submission-to-fda-302905102.html","https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230027.pdf","https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254230.pdf"]}],"method":"controlled-rules-v1","rule_id":"computing-it","status":"candidate"}],"taxonomy_revision":"1f2db31d811fca07e99b16d402c10e2cc2965c9df1c7b41d9be348b40a24e7fb","taxonomy_version":"IPTC Media Topics 2026-Q2"},"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=en","category":"technology","content":{"key_points":[],"paragraphs":["Texas-based capsule-endoscopy company AnX Robotica highlighted clinical results in the FDA file for NaviCam ProScan on October 11. ProScan received its De Novo decision on December 12, 2023, so the announcement was not a new clearance. AnX revisited the earlier ProScan data after the FDA separately cleared CapsoVision’s CapsoView and CapsoCloud software through a 510(k) decision on September 25, 2026. The ARTIC analysis in the FDA file included 133 patients; mean small-bowel image review time was 33 minutes 42 seconds with standard physician reading and 3 minutes 50 seconds when physicians used AI assistance. The reduction calculated from those figures is 88.6%.","The FDA file reported diagnostic yields for significant lesions of 62.4% with standard reading and 73.7% with AI-assisted physician reading. AnX’s release also presented timing results from the separate FDA review of the competing software, but the studies used different systems and designs and were not head-to-head tests; they do not establish direct superiority between products. The FDA says ProScan assists physician review, is not a stand-alone diagnostic tool and does not replace clinical decision-making."],"sections":[]},"corrections":[],"country":"US","data":{"blocks":[{"description":{"ar":"عدد المشاركين ونتائج زمن المراجعة في دراسة ARTIC الاستباقية الواردة في ملف FDA لمسار De Novo.","de":"Teilnehmerzahl und Prüfzeit-Ergebnisse der prospektiven ARTIC-Studie in der De-Novo-Akte der FDA.","en":"Participant count and review-time results from the prospective ARTIC study in the FDA De Novo file.","es":"Número de participantes y resultados de tiempo de revisión del estudio prospectivo ARTIC que figura en el expediente De Novo de la FDA.","fr":"Nombre de participants et résultats sur le temps d’examen de l’étude prospective ARTIC figurant dans le dossier De Novo de la FDA.","pt":"Número de participantes e resultados de tempo de análise do estudo prospectivo ARTIC no processo De Novo da FDA.","tr":"FDA’nın De Novo dosyasındaki ileriye dönük ARTIC çalışmasının katılımcı sayısı ve inceleme süresi sonuçları."},"id":"proscan-artic-study-results","items":[{"basis":"observed","label":{"ar":"المرضى المشمولون في تحليل ARTIC","de":"In die ARTIC-Auswertung einbezogene Patienten","en":"Patients included in the ARTIC analysis","es":"Pacientes incluidos en el análisis ARTIC","fr":"Patients inclus dans l’analyse ARTIC","pt":"Pacientes incluídos na análise ARTIC","tr":"ARTIC analizine dahil edilen hasta sayısı"},"measure":{"aggregation":"unspecified","frequency":"irregular","geography":"europe","id":"proscan-artic-patients-analyzed","periodRole":"reference-period","unitCode":"count"},"period":"2022-01","periodStart":"2021-02","unit":"patients","value":133},{"basis":"observed","label":{"ar":"الانخفاض في زمن مراجعة صور الأمعاء الدقيقة مع قراءة الطبيب بمساعدة الذكاء الاصطناعي","de":"Verringerung der Prüfzeit für Dünndarmbilder bei KI-gestützter ärztlicher Auswertung","en":"Reduction in small-bowel image review time with AI-assisted physician reading","es":"Reducción del tiempo de revisión de imágenes del intestino delgado con lectura médica asistida por IA","fr":"Réduction du temps d’examen des images de l’intestin grêle avec lecture médicale assistée par l’IA","pt":"Redução do tempo de análise de imagens do intestino delgado com leitura médica assistida por IA","tr":"Yapay zekâ yardımlı doktor incelemesinde ince bağırsak görüntüsü inceleme süresindeki azalma"},"measure":{"aggregation":"unspecified","frequency":"irregular","geography":"europe","id":"proscan-artic-ai-assisted-review-time-reduction","periodRole":"reference-period","unitCode":"percent"},"period":"2022-01","periodStart":"2021-02","unit":"percent","value":88.6}],"methodology":{"ar":"عدد المرضى ومتوسطا زمن المراجعة من ملخص FDA لمسار De Novo. حُسب الانخفاض البالغ 88.6% من المتوسطين المنشورين، 33 دقيقة و42 ثانية و3 دقائق و50 ثانية، ثم قُرّب إلى منزلة عشرية واحدة. وأُجريت الدراسة من فبراير 2021 إلى يناير 2022 في سبعة مراكز أوروبية؛ وليست مقارنة مباشرة مع الدراسة المنفصلة لمنتج منافس.","de":"Patientenzahl und mittlere Prüfzeiten stammen aus der De-Novo-Zusammenfassung der FDA. Die Verringerung um 88,6 Prozent wurde aus den veröffentlichten Mittelwerten von 33 Minuten 42 Sekunden und 3 Minuten 50 Sekunden berechnet und auf eine Dezimalstelle gerundet. Die Studie lief von Februar 2021 bis Januar 2022 an sieben europäischen Zentren; sie ist kein direkter Vergleich mit der separaten Studie eines Konkurrenzprodukts.","en":"Patient count and mean review times are from the FDA De Novo summary. The 88.6% reduction is calculated from the reported means of 33 minutes 42 seconds and 3 minutes 50 seconds, then rounded to one decimal place. The study ran from February 2021 through January 2022 at seven European centers; it is not a head-to-head comparison with the separate study of a competing product.","es":"El número de pacientes y los tiempos medios proceden del resumen De Novo de la FDA. La reducción del 88,6% se calcula a partir de las medias publicadas de 33 minutos y 42 segundos y de 3 minutos y 50 segundos, y se redondea a un decimal. El estudio se realizó entre febrero de 2021 y enero de 2022 en siete centros europeos; no es una comparación directa con el estudio separado de un producto competidor.","fr":"Le nombre de patients et les temps moyens proviennent du résumé De Novo de la FDA. La baisse de 88,6 % est calculée à partir des moyennes publiées de 33 minutes 42 secondes et de 3 minutes 50 secondes, puis arrondie à une décimale. L’étude s’est déroulée de février 2021 à janvier 2022 dans sept centres européens ; elle ne compare pas directement ProScan à l’étude distincte d’un produit concurrent.","pt":"O número de pacientes e os tempos médios vêm do resumo De Novo da FDA. A redução de 88,6% foi calculada a partir das médias informadas de 33 minutos e 42 segundos e 3 minutos e 50 segundos, com arredondamento para uma casa decimal. O estudo ocorreu de fevereiro de 2021 a janeiro de 2022 em sete centros europeus; não é uma comparação direta com o estudo separado de um produto concorrente.","tr":"Katılımcı sayısı ve ortalama inceleme süreleri FDA De Novo özetinden alınmıştır. Yüzde 88,6 azalma, kaynakta verilen 33 dakika 42 saniye ve 3 dakika 50 saniye ortalamalarından hesaplanmış ve bir ondalığa yuvarlanmıştır. Çalışma Şubat 2021-Ocak 2022 arasında Avrupa’daki yedi merkezde yürütülmüştür; rakip ürünün ayrı çalışmasıyla başa baş karşılaştırma değildir."},"sourceUrls":["https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230027.pdf","https://www.prnewswire.com/news-releases/anx-robotica-highlights-documented-proscan-ai-workflow-performance-from-submission-to-fda-302905102.html"],"title":{"ar":"نتائج دراسة ARTIC لبرنامج ProScan","de":"Ergebnisse der ARTIC-Studie zu ProScan","en":"ProScan ARTIC study results","es":"Resultados del estudio ARTIC de ProScan","fr":"Résultats de l’étude ARTIC sur ProScan","pt":"Resultados do estudo ARTIC do ProScan","tr":"ProScan ARTIC çalışma sonuçları"},"type":"metrics","updatedAt":"2026-10-11T20:30:02Z"}],"version":1},"data_downloads":[{"formats":{"csv":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times/data/proscan-artic-study-results?lang=en&format=csv","json":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times/data/proscan-artic-study-results?lang=en&format=json"},"id":"proscan-artic-study-results"}],"data_types":["metrics"],"editorial_illustration":{"alt":"Conceptual illustration of technology, processors and connected 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information.","asset_id":"newsverum-v1-technology","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"en","scope":"section","url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/technology-1536.webp","width":1536}],"width":1536},"slug":"anx-proscan-fda-reading-times","sources":[{"checkedAt":"2026-10-11","name":"AnX Robotica via PR Newswire","publishedAt":"2026-10-11","url":"https://www.prnewswire.com/news-releases/anx-robotica-highlights-documented-proscan-ai-workflow-performance-from-submission-to-fda-302905102.html"},{"checkedAt":"2026-10-11","name":"U.S. Food and Drug Administration, De Novo Classification Request DEN230027","publishedAt":"2023-12-12","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230027.pdf"},{"checkedAt":"2026-10-11","name":"U.S. Food and Drug Administration, 510(k) Summary K254230","publishedAt":"2026-09-25","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254230.pdf"}],"summary":"After a separate FDA clearance for another software platform on September 25, 2026, the company highlighted earlier FDA-filed clinical results for ProScan.","text":"After a separate FDA clearance for another software platform on September 25, 2026, the company highlighted earlier FDA-filed clinical results for ProScan.\n\nTexas-based capsule-endoscopy company AnX Robotica highlighted clinical results in the FDA file for NaviCam ProScan on October 11. ProScan received its De Novo decision on December 12, 2023, so the announcement was not a new clearance. AnX revisited the earlier ProScan data after the FDA separately cleared CapsoVision’s CapsoView and CapsoCloud software through a 510(k) decision on September 25, 2026. The ARTIC analysis in the FDA file included 133 patients; mean small-bowel image review time was 33 minutes 42 seconds with standard physician reading and 3 minutes 50 seconds when physicians used AI assistance. The reduction calculated from those figures is 88.6%.\n\nThe FDA file reported diagnostic yields for significant lesions of 62.4% with standard reading and 73.7% with AI-assisted physician reading. AnX’s release also presented timing results from the separate FDA review of the competing software, but the studies used different systems and designs and were not head-to-head tests; they do not establish direct superiority between products. The FDA says ProScan assists physician review, is not a stand-alone diagnostic tool and does not replace clinical decision-making.","title":"AnX cites FDA data on AI-assisted capsule image review times","topics":[],"translations":[{"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=tr","language":"tr","url":"https://newsverum.com/tr/news/anx-proscan-fda-reading-times"},{"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=en","language":"en","url":"https://newsverum.com/en/news/anx-proscan-fda-reading-times"},{"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=ar","language":"ar","url":"https://newsverum.com/ar/news/anx-proscan-fda-reading-times"},{"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=fr","language":"fr","url":"https://newsverum.com/fr/news/anx-proscan-fda-reading-times"},{"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=es","language":"es","url":"https://newsverum.com/es/news/anx-proscan-fda-reading-times"},{"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=de","language":"de","url":"https://newsverum.com/de/news/anx-proscan-fda-reading-times"},{"api_url":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times?lang=pt","language":"pt","url":"https://newsverum.com/pt/news/anx-proscan-fda-reading-times"}],"url":"https://newsverum.com/en/news/anx-proscan-fda-reading-times"},"version":"1"}