{"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=es","category":"technology","content":{"key_points":[],"paragraphs":["El 11 de octubre, AnX Robotica, empresa de endoscopia con cápsula radicada en Texas, destacó resultados clínicos del expediente de la FDA sobre NaviCam ProScan. ProScan recibió su decisión De Novo el 12 de diciembre de 2023, por lo que el anuncio no era una nueva autorización. AnX volvió a presentar los datos anteriores de ProScan después de que la FDA autorizara por separado el software CapsoView y CapsoCloud de CapsoVision mediante una decisión 510(k) del 25 de septiembre de 2026. El análisis ARTIC del expediente de la FDA abarcó a 133 pacientes; el tiempo medio para revisar imágenes del intestino delgado fue de 33 minutos y 42 segundos con lectura médica estándar y de 3 minutos y 50 segundos con asistencia de IA. La reducción calculada a partir de esas cifras es del 88,6%.","El expediente de la FDA registró un rendimiento diagnóstico de lesiones relevantes del 62,4% con lectura estándar y del 73,7% con lectura médica asistida por IA. El comunicado de AnX también presentó tiempos de la evaluación separada de la FDA sobre el software competidor, pero los estudios emplearon sistemas y diseños distintos y no fueron una prueba directa; no demuestran la superioridad de un producto sobre otro. La FDA indica que ProScan ayuda al profesional en la revisión, no es una herramienta diagnóstica independiente y no sustituye el criterio clínico."],"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=es&format=csv","json":"https://newsverum.com/api/v1/articles/anx-proscan-fda-reading-times/data/proscan-artic-study-results?lang=es&format=json"},"id":"proscan-artic-study-results"}],"data_types":["metrics"],"editorial_illustration":{"alt":"Ilustración conceptual de tecnología, procesadores e información 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conceptual de tecnología, procesadores e información 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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":"Tras una autorización separada de la FDA para otro software el 25 de septiembre de 2026, la empresa destacó resultados clínicos anteriores del expediente de ProScan.","text":"Tras una autorización separada de la FDA para otro software el 25 de septiembre de 2026, la empresa destacó resultados clínicos anteriores del expediente de ProScan.\n\nEl 11 de octubre, AnX Robotica, empresa de endoscopia con cápsula radicada en Texas, destacó resultados clínicos del expediente de la FDA sobre NaviCam ProScan. ProScan recibió su decisión De Novo el 12 de diciembre de 2023, por lo que el anuncio no era una nueva autorización. AnX volvió a presentar los datos anteriores de ProScan después de que la FDA autorizara por separado el software CapsoView y CapsoCloud de CapsoVision mediante una decisión 510(k) del 25 de septiembre de 2026. El análisis ARTIC del expediente de la FDA abarcó a 133 pacientes; el tiempo medio para revisar imágenes del intestino delgado fue de 33 minutos y 42 segundos con lectura médica estándar y de 3 minutos y 50 segundos con asistencia de IA. La reducción calculada a partir de esas cifras es del 88,6%.\n\nEl expediente de la FDA registró un rendimiento diagnóstico de lesiones relevantes del 62,4% con lectura estándar y del 73,7% con lectura médica asistida por IA. El comunicado de AnX también presentó tiempos de la evaluación separada de la FDA sobre el software competidor, pero los estudios emplearon sistemas y diseños distintos y no fueron una prueba directa; no demuestran la superioridad de un producto sobre otro. La FDA indica que ProScan ayuda al profesional en la revisión, no es una herramienta diagnóstica independiente y no sustituye el criterio clínico.","title":"AnX cita datos de la FDA sobre el tiempo de revisión de imágenes de cápsula con IA","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/es/news/anx-proscan-fda-reading-times"},"version":"1"}