{"data":[{"id":"0ca0ebb0-959d-4972-90fe-9507f737ca89","company_name":"株式会社UT-Heart研究所","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["先駆け審査指定制度対象品目の募集"],"regional_record_count":1,"source_document_count":1,"law_name":"薬事法","action_type":"先駆け審査指定制度対象品目の募集","action_date":"2017-10-05","announcement_date":"2026-04-03","violation_summary":"UT-Heart 心臓再同期療法の効果予測","violation_summary_en":"Prediction of the effect of UT-Heart cardiac resynchronization therapy","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000179802.html","url":"https://regbase.jp/enforcement/other-ut-heartyan-jiu-suo-20171005"},{"id":"3e22c6f2-e456-4ce3-8090-bf5332b2e9d5","company_name":"株式会社UT-Heart研究所","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬事法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-04-07","violation_summary":"心臓再同期療法※を行った重症心不全患者の中で約30％が無効例と報告されており、無効例の診断は困難である。本品は心臓再同期療法の効果予測の判断を補助できる点に新規性があり、画期性が高い。臨床研究（11例）の結果から、本品を使用した心臓のポンプ機能の改善の効果予測は実際の効果と高い相関（相関係数0.94）を示したとの報告があり、高い有効性が期待できる。","violation_summary_en":"Approximately 30% of patients with severe heart failure who underwent cardiac resynchronization therapy (CRT) were reported to have ineffective outcomes, and diagnosing ineffective cases is difficult. The product has novelty and high significance in that it can assist in predicting the effectiveness of CRT. Clinical research (11 cases) reported that the prediction of improvement in cardiac pump function using the product showed a high correlation (correlation coefficient 0.94) with actual effects, indicating high potential efficacy.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-ut-heartyan-jiu-suo-20170228"}],"meta":{"query":"株式会社UT-Heart研究所","corporate_number":null,"law":null,"authority":null,"action_type":null,"count":2,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":5,"reset_at":"2026-08-04T17:35:57.993Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":117,"reset_at":"2026-08-05T17:34:57.993Z"}}}