[
  {"device_id": "K233101", "jurisdiction": "FDA", "sponsor": "Dexcom, Inc.", "product_code": "QBJ", "decision_date": "2026-01-12", "decision_type": "510(k)", "indication": "Continuous glucose monitoring in adults and pediatric patients aged 2 years and older with diabetes", "predicate_device": "K221234 (Dexcom G7)", "class": "II", "samd_classification": "Class III (IMDRF)", "label_change": "iCGM designation reaffirmed; integration with AID systems expanded", "device_category": "CGM", "device_name": "Dexcom G8"},
  {"device_id": "P210027/S012", "jurisdiction": "FDA", "sponsor": "Medtronic MiniMed", "product_code": "OYC", "decision_date": "2026-02-18", "decision_type": "PMA Supplement", "indication": "Hybrid closed-loop system for type 1 diabetes ages 7+", "predicate_device": "MiniMed 780G base PMA", "class": "III", "samd_classification": "Class IV (IMDRF)", "label_change": "Aggressive target 100 mg/dL expanded; meal detection algorithm v3", "device_category": "AID", "device_name": "MiniMed 780G v3"},
  {"device_id": "DEN230018", "jurisdiction": "FDA", "sponsor": "Beta Bionics", "product_code": "QFG", "decision_date": "2026-03-05", "decision_type": "De Novo", "indication": "Bionic pancreas for adults with type 1 diabetes; no carb counting", "predicate_device": "N/A (De Novo)", "class": "II (special controls)", "samd_classification": "Class IV (IMDRF)", "label_change": "Pediatric ages 6-17 added", "device_category": "AID", "device_name": "iLet Bionic Pancreas (Peds)"},
  {"device_id": "K240412", "jurisdiction": "FDA", "sponsor": "Tandem Diabetes Care", "product_code": "OYC", "decision_date": "2026-02-28", "decision_type": "510(k)", "indication": "Control-IQ technology with mobile bolus updates", "predicate_device": "K223210 (t:slim X2 Control-IQ)", "class": "II", "samd_classification": "Class III (IMDRF)", "label_change": "Mobile bolus from iOS/Android approved", "device_category": "AID", "device_name": "Tandem Mobi w/ Control-IQ+"},
  {"device_id": "K243377", "jurisdiction": "FDA", "sponsor": "Abbott Diabetes Care", "product_code": "QBJ", "decision_date": "2026-04-09", "decision_type": "510(k)", "indication": "15-day wear iCGM for adults and children >=4 years", "predicate_device": "K230945 (FreeStyle Libre 3)", "class": "II", "samd_classification": "Class III (IMDRF)", "label_change": "Wear extended to 15 days; MARD 7.9%", "device_category": "CGM", "device_name": "FreeStyle Libre 4"},
  {"device_id": "K241502", "jurisdiction": "FDA", "sponsor": "Insulet Corporation", "product_code": "OYC", "decision_date": "2026-03-18", "decision_type": "510(k)", "indication": "Tubeless AID with SmartAdjust technology; type 2 diabetes adults", "predicate_device": "K223544 (Omnipod 5)", "class": "II", "samd_classification": "Class III (IMDRF)", "label_change": "Type 2 indication added", "device_category": "AID", "device_name": "Omnipod 5 (T2D label)"},
  {"device_id": "K240881", "jurisdiction": "FDA", "sponsor": "Bigfoot Biomedical", "product_code": "QBI", "decision_date": "2026-01-30", "decision_type": "510(k)", "indication": "Connected smart insulin pen cap with dose decision support", "predicate_device": "K203615 (Bigfoot Unity)", "class": "II", "samd_classification": "Class III (IMDRF)", "label_change": "CGM integration with Libre 3 added", "device_category": "PEN", "device_name": "Bigfoot Unity 2"},
  {"device_id": "K233812", "jurisdiction": "FDA", "sponsor": "Digital Diagnostics", "product_code": "PIB", "decision_date": "2026-02-02", "decision_type": "510(k)", "indication": "Autonomous AI for diabetic retinopathy detection in primary care", "predicate_device": "DEN180001 (IDx-DR)", "class": "II", "samd_classification": "Class III (IMDRF)", "label_change": "Specificity improved; new fundus camera supported", "device_category": "SaMD", "device_name": "LumineticsCore (IDx-DR v3)"},
  {"device_id": "K241988", "jurisdiction": "FDA", "sponsor": "Eyenuk, Inc.", "product_code": "PIB", "decision_date": "2026-03-12", "decision_type": "510(k)", "indication": "AI-based DR screening including more-than-mild DR and vision-threatening DR", "predicate_device": "K200667 (EyeArt)", "class": "II", "samd_classification": "Class III (IMDRF)", "label_change": "Vision-threatening DR detection expanded", "device_category": "SaMD", "device_name": "EyeArt v3"},
  {"device_id": "DEN240007", "jurisdiction": "FDA", "sponsor": "Better Therapeutics", "product_code": "QPL", "decision_date": "2026-04-22", "decision_type": "De Novo", "indication": "Prescription digital therapeutic for type 2 diabetes (CBT-based)", "predicate_device": "N/A", "class": "II (special controls)", "samd_classification": "Class III (IMDRF)", "label_change": "Initial clearance; HbA1c reduction claim", "device_category": "DTx", "device_name": "AspyreRx"},
  {"device_id": "K242211", "jurisdiction": "FDA", "sponsor": "Movano Health", "product_code": "QBJ-W", "decision_date": "2026-04-30", "decision_type": "510(k)", "indication": "Investigational non-invasive wearable for glucose trending (research label)", "predicate_device": "N/A pre-submission Q-Sub", "class": "II", "samd_classification": "Class II (IMDRF)", "label_change": "Wellness-only label; non-diagnostic", "device_category": "WEARABLE", "device_name": "Evie Ring (glucose research mode)"},
  {"device_id": "EUDAMED-CIV-26-001234", "jurisdiction": "EU", "sponsor": "Roche Diabetes Care", "product_code": "MDR Annex VIII Rule 11", "decision_date": "2026-01-22", "decision_type": "MDR CE Mark", "indication": "Integrated CGM + insulin pump system; pediatric+adult", "predicate_device": "Accu-Chek Solo CE 2019", "class": "IIb", "samd_classification": "Class III (IMDRF)", "label_change": "MDR transition complete from MDD", "device_category": "AID", "device_name": "Accu-Chek SmartGuide Plus"},
  {"device_id": "EUDAMED-AI-26-000891", "jurisdiction": "EU", "sponsor": "Mediwhale (메디웨일)", "product_code": "MDR Rule 11 + AI Act high-risk", "decision_date": "2026-03-28", "decision_type": "MDR CE Mark + AI Act registration", "indication": "AI-based cardiovascular and diabetic complication risk from fundus", "predicate_device": "Reti-CVD CE 2023", "class": "IIa", "samd_classification": "Class III (IMDRF)", "label_change": "AI Act Annex III high-risk system registered", "device_category": "SaMD", "device_name": "Dr. Noon (닥터누) EU"},
  {"device_id": "EUDAMED-DTx-26-000445", "jurisdiction": "EU", "sponsor": "Kaia Health / Oviva", "product_code": "DiGA-eligible MDR Class IIa", "decision_date": "2026-02-14", "decision_type": "DiGA permanent listing (BfArM)", "indication": "Digital therapeutic for type 2 diabetes self-management; German reimbursement", "predicate_device": "Provisional DiGA 2024", "class": "IIa", "samd_classification": "Class III (IMDRF)", "label_change": "DiGA fast-track to permanent; reimbursement code assigned", "device_category": "DTx", "device_name": "Oviva Direkt für Diabetes Typ 2"},
  {"device_id": "MFDS-2026-제1245호", "jurisdiction": "KFDA", "sponsor": "휴이노 (HUINNO)", "product_code": "A26030.03 의료용센서식 혈당측정기", "decision_date": "2026-01-15", "decision_type": "KFDA 4등급 의료기기 허가", "indication": "성인 당뇨병 환자의 연속혈당측정 (한국 식약처 허가)", "predicate_device": "MFDS-2024-제0987호", "class": "4등급", "samd_classification": "Class III (IMDRF)", "label_change": "한국인 임상 320례 추가, 정확도 MARD 8.4%", "device_category": "CGM", "device_name": "HUINNO CGM-K"},
  {"device_id": "MFDS-2026-제1387호", "jurisdiction": "KFDA", "sponsor": "뷰노 (VUNO Inc.)", "product_code": "A26280.01 안저영상진단보조소프트웨어", "decision_date": "2026-02-26", "decision_type": "KFDA 3등급 SaMD 허가 (혁신의료기기)", "indication": "당뇨병성 망막병증 보조 진단 AI", "predicate_device": "VUNO Med-Fundus AI 2021", "class": "3등급", "samd_classification": "Class III (IMDRF)", "label_change": "혁신의료기기 지정 + 신의료기술평가 유예", "device_category": "SaMD", "device_name": "VUNO Med-Fundus AI v3 (당뇨망막)"},
  {"device_id": "MFDS-2026-제1422호", "jurisdiction": "KFDA", "sponsor": "메디웨일 (Mediwhale)", "product_code": "A26280.02 심혈관위험분석소프트웨어", "decision_date": "2026-03-09", "decision_type": "KFDA 3등급 허가 + 혁신의료기기", "indication": "당뇨병 환자 심혈관·신장 합병증 위험 예측 (안저영상)", "predicate_device": "메디웨일 Reti-CVD 2022", "class": "3등급", "samd_classification": "Class III (IMDRF)", "label_change": "당뇨신증 예측 indication 추가", "device_category": "SaMD", "device_name": "닥터누 (Dr. Noon) 당뇨 모듈"},
  {"device_id": "MFDS-DTx-2026-제0008호", "jurisdiction": "KFDA", "sponsor": "웰트 (WELT Corp.)", "product_code": "디지털치료기기 (A99000)", "decision_date": "2026-04-11", "decision_type": "KFDA 디지털치료기기 인증 (2등급)", "indication": "제2형 당뇨병 환자 라이프스타일 중재 DTx", "predicate_device": "WELT-I 불면증 DTx 2023", "class": "2등급", "samd_classification": "Class II (IMDRF)", "label_change": "국내 두 번째 DTx 인증, KDA 가이드라인 정합", "device_category": "DTx", "device_name": "WELT-DM (당뇨 라이프스타일)"},
  {"device_id": "MFDS-2026-제1499호", "jurisdiction": "KFDA", "sponsor": "아이센스 (i-SENS)", "product_code": "A26030.03 CGM", "decision_date": "2026-04-25", "decision_type": "KFDA 4등급 허가", "indication": "14일 착용 CGM, 한국인 성인·소아 4세 이상", "predicate_device": "CareSens Air 2024", "class": "4등급", "samd_classification": "Class III (IMDRF)", "label_change": "착용기간 14일로 연장, 보정 불필요", "device_category": "CGM", "device_name": "CareSens Air Pro"},
  {"device_id": "MFDS-2026-제1556호", "jurisdiction": "KFDA", "sponsor": "이오플로우 (EOFlow)", "product_code": "A77010 인슐린주입펌프", "decision_date": "2026-05-02", "decision_type": "KFDA 4등급 허가", "indication": "튜브리스 패치형 인슐린펌프; AID 알고리즘 통합", "predicate_device": "EOPatch 2022", "class": "4등급", "samd_classification": "Class IV (IMDRF)", "label_change": "AID 알고리즘 통합 인허가, Libre/CareSens 연동", "device_category": "AID", "device_name": "EOPatch X (AID 통합)"},
  {"device_id": "MHRA-MFR-2026-2211", "jurisdiction": "MHRA", "sponsor": "Dexcom UK Ltd.", "product_code": "UKCA Class IIb", "decision_date": "2026-02-08", "decision_type": "UKCA Mark", "indication": "iCGM for ages 2+ with diabetes (UK NHS reimbursement-aligned)", "predicate_device": "Dexcom G7 CE 2023", "class": "IIb", "samd_classification": "Class III (IMDRF)", "label_change": "UKCA transition from CE; NHS Supply Chain catalog", "device_category": "CGM", "device_name": "Dexcom G7 (UKCA)"},
  {"device_id": "MHRA-AI-2026-0341", "jurisdiction": "MHRA", "sponsor": "Optos / Google Health", "product_code": "UKCA Class IIa SaMD + MHRA AI Airlock", "decision_date": "2026-03-20", "decision_type": "MHRA AI Airlock pilot exit", "indication": "AI-based DR screening within NHS Diabetic Eye Screening Programme", "predicate_device": "N/A Airlock", "class": "IIa", "samd_classification": "Class III (IMDRF)", "label_change": "Airlock pilot exit; NHS DESP integration approved", "device_category": "SaMD", "device_name": "ARDA (Automated Retinal Disease Assessment)"},
  {"device_id": "PMDA-26-Iyaku-105", "jurisdiction": "PMDA", "sponsor": "Terumo Corporation", "product_code": "JMDN 70030020 持続血糖測定器", "decision_date": "2026-01-29", "decision_type": "PMDA 承認 (Shounin)", "indication": "成人および小児（6歳以上）の糖尿病における持続血糖測定", "predicate_device": "MediSafe Witty CGM 2024", "class": "高度管理医療機器 (Class III)", "samd_classification": "Class III (IMDRF)", "label_change": "適応年齢拡大、保険点数申請中", "device_category": "CGM", "device_name": "Terumo MediSafe CGM 2"},
  {"device_id": "PMDA-26-Iyaku-238", "jurisdiction": "PMDA", "sponsor": "Medtronic Japan", "product_code": "JMDN 36880000 自動インスリン注入システム", "decision_date": "2026-04-04", "decision_type": "PMDA 承認 + SAKIGAKE", "indication": "1型糖尿病成人および小児のためのハイブリッドクローズドループ", "predicate_device": "MiniMed 770G 2021", "class": "高度管理医療機器 (Class IV)", "samd_classification": "Class IV (IMDRF)", "label_change": "SAKIGAKE 指定で優先審査、日本初の AID 完全承認", "device_category": "AID", "device_name": "MiniMed 780G Japan"},
  {"device_id": "NMPA-2026-3-001245", "jurisdiction": "NMPA", "sponsor": "Microtech Medical (圣美迪诺)", "product_code": "6822 持续葡萄糖监测系统", "decision_date": "2026-02-22", "decision_type": "NMPA Class III 注册", "indication": "成人糖尿病患者持续葡萄糖监测", "predicate_device": "雅培瞬感 (Libre) reference", "class": "III类", "samd_classification": "Class III (IMDRF)", "label_change": "国产 implantable 360日 CGM 首批 NMPA 批准", "device_category": "CGM", "device_name": "微泰 Equil Long-term CGM"},
  {"device_id": "NMPA-2026-3-002001", "jurisdiction": "NMPA", "sponsor": "Airdoc (鹰瞳科技)", "product_code": "6821 软件 AI辅助诊断", "decision_date": "2026-03-15", "decision_type": "NMPA Class III SaMD", "indication": "糖尿病视网膜病变 AI 辅助诊断", "predicate_device": "Airdoc-AIFUNDUS 1.0 2020", "class": "III类", "samd_classification": "Class III (IMDRF)", "label_change": "新增青光眼+AMD 多疾病联合检测", "device_category": "SaMD", "device_name": "Airdoc-AIFUNDUS 3.0"},
  {"device_id": "HC-MDL-2026-105467", "jurisdiction": "HC", "sponsor": "Dexcom Canada Co.", "product_code": "MDALL 99876", "decision_date": "2026-02-11", "decision_type": "Health Canada Class III License", "indication": "iCGM for Canadian diabetes population; CADTH-aligned", "predicate_device": "Dexcom G7 license 2023", "class": "III", "samd_classification": "Class III (IMDRF)", "label_change": "Pediatric ages 2+ harmonized with FDA", "device_category": "CGM", "device_name": "Dexcom G8 (Canada)"},
  {"device_id": "HC-MDL-2026-106102", "jurisdiction": "HC", "sponsor": "Insulet Canada", "product_code": "MDALL 100231", "decision_date": "2026-04-18", "decision_type": "Health Canada Class III License", "indication": "Tubeless AID with SmartAdjust; T1D and T2D adults", "predicate_device": "Omnipod 5 license 2024", "class": "III", "samd_classification": "Class III (IMDRF)", "label_change": "T2D indication added, provincial reimbursement filings open", "device_category": "AID", "device_name": "Omnipod 5 Canada (T2D)"},
  {"device_id": "TGA-ARTG-2026-405211", "jurisdiction": "TGA", "sponsor": "Abbott Australasia", "product_code": "GMDN 35711 CGM", "decision_date": "2026-03-02", "decision_type": "TGA ARTG inclusion Class IIb", "indication": "15-day iCGM, NDSS subsidy expansion under review", "predicate_device": "Libre 3 ARTG 2024", "class": "IIb", "samd_classification": "Class III (IMDRF)", "label_change": "NDSS subsidy submission accepted by PBAC", "device_category": "CGM", "device_name": "FreeStyle Libre 4 (AU)"},
  {"device_id": "TGA-AI-2026-019", "jurisdiction": "TGA", "sponsor": "Eyenuk Australia", "product_code": "GMDN 65420 AI SaMD", "decision_date": "2026-04-29", "decision_type": "TGA ARTG inclusion Class IIb", "indication": "AI DR screening for primary care, MBS item proposal", "predicate_device": "EyeArt 2.0 ARTG 2024", "class": "IIb", "samd_classification": "Class III (IMDRF)", "label_change": "Indigenous health DR program eligibility", "device_category": "SaMD", "device_name": "EyeArt v3 (AU)"},
  {"device_id": "K243990", "jurisdiction": "FDA", "sponsor": "Senseonics, Inc.", "product_code": "QBJ", "decision_date": "2026-05-06", "decision_type": "PMA Supplement", "indication": "365-day implantable CGM with no fingerstick calibration", "predicate_device": "Eversense E3 PMA", "class": "III", "samd_classification": "Class III (IMDRF)", "label_change": "365-day wear approved; iCGM designation pursued", "device_category": "CGM", "device_name": "Eversense 365"},
  {"device_id": "MFDS-2026-제1602호", "jurisdiction": "KFDA", "sponsor": "노을 (Noul Co.)", "product_code": "A26280 AI 진단보조 SW", "decision_date": "2026-05-09", "decision_type": "KFDA 3등급 허가", "indication": "현미경 영상 기반 당뇨신증 조직병리 AI 보조", "predicate_device": "miLab AI 2024", "class": "3등급", "samd_classification": "Class III (IMDRF)", "label_change": "당뇨신증 신청 indication 추가, 닥터앤서 3.0 컨소시엄 연계", "device_category": "SaMD", "device_name": "miLab DKD"},
  {"device_id": "MFDS-2026-제1631호", "jurisdiction": "KFDA", "sponsor": "셀바스헬스케어", "product_code": "A77010 인슐린펜 캡", "decision_date": "2026-05-11", "decision_type": "KFDA 2등급 허가", "indication": "스마트 인슐린 펜캡, 한국인 T1D/T2D", "predicate_device": "기존 펜캡 2024", "class": "2등급", "samd_classification": "Class II (IMDRF)", "label_change": "한국어 음성 안내, CGM(아이센스) 연동", "device_category": "PEN", "device_name": "Selvas Smart Pen Cap KR"},
  {"device_id": "EUDAMED-DTx-26-000612", "jurisdiction": "EU", "sponsor": "Sidekick Health", "product_code": "DiGA-listed MDR IIa", "decision_date": "2026-04-02", "decision_type": "DiGA preliminary listing", "indication": "Digital therapy program for prediabetes prevention", "predicate_device": "N/A", "class": "IIa", "samd_classification": "Class III (IMDRF)", "label_change": "12-month preliminary listing in DiGA registry", "device_category": "DTx", "device_name": "Sidekick Prediabetes"}
]