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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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UPDATED
규제 업데이트
2026년 8월 28일•1분 읽기
Cynosure DermaV Laser System Reports Spark Noise and Burn Risks in Vascular Treatments
Cynosure Lutronic reports patient burn incidents linked to spark and loud noise during DermaV laser vascular procedures.
UPDATED
규제 업데이트
2026년 8월 28일•1분 읽기
Cynosure DermaV Laser System Linked to Spark-Related Burns in North America
Cynosure Lutronic reports an adverse trend of spark and loud noise complaints causing patient burns during vascular treatments with the DermaV laser system.
UPDATED
규제 업데이트
2026년 8월 26일•1분 읽기
Draeger alerts users to hose cracks in VentStar Resus Neo and Resuscitaire devices
Draeger reports observed hose cracks in VentStar Resus Neo and Resuscitaire; no confirmed patient harm yet.
UPDATED
규제 업데이트
2026년 8월 26일•1분 읽기
Draeger Alerts Potential Hose Cracks in VentStar Resus Neo and Resuscitaire Devices
Draeger reports users have found visible hose cracks in VentStar® Resus Neo and Resuscitaire devices before use; no health impacts reported but risk cannot be excluded.
UPDATED
규제 업데이트
2026년 8월 25일•2분 읽기
MHRA August 2026 Safety Roundup: Ventilator PCBA Fault, Anaesthesia Workstation Defect, Belzer Solution Update
The August 2026 MHRA safety roundup highlights a ResMed ventilator PCBA leak risk, a Dräger anaesthesia workstation piston failure, and updated guidance on Belzer organ‑preservation solutions.
UPDATED
규제 업데이트
2026년 8월 25일•1분 읽기
MHRA Introduces Patient Alert Card for Finasteride Users
A new patient alert card warns men on finasteride of psychiatric side effects and persistent sexual dysfunction.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
Recall of Edwards ForeSight™ Oximeter Cable for Inaccurate StO2 Readings
Edwards reports that mislabelled sensor cables on the ForeSight™ Oximeter may cause swapped left/right StO2 values, risking misdiagnosis.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Publishes Updated Safety and Educational Materials
MHRA releases new safety and educational resources to support regulatory measures from the 2023 Patient Safety Alert and 2024 Drug Safety Update.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Announces MedSafetyWeek 2025 Theme: ‘We Can All Help Make Medicines Safer’
The MHRA’s annual MedSafetyWeek runs 3‑9 Nov 2025, focusing on the theme ‘we can all help make medicines safer’.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
PMDA Safety Notice: Incorrect Dose Risks with Insulin‑Specific Syringes
The Pharmaceuticals and Medical Devices Agency (PMDA) issued a safety alert warning that using insulin‑specific syringes incorrectly may cause serious adverse health effects.
UPDATED
규제 업데이트
2026년 8월 23일•1분 읽기
Risk of Severe Harm from Using Incorrect IV Giving Set for Blood Transfusion
Using an IV infusion giving set instead of a blood transfusion set may cause serious patient harm.
UPDATED
규제 업데이트
2026년 8월 23일•1분 읽기
ResMed Field Safety Notice: Astral 100/150 Ventilators May Interrupt Therapy
ResMed issued a Field Safety Notice for Astral 100 and 150 ventilators and related PCB spare parts made before Oct 2024, citing a fault that could unexpectedly interrupt ventilation.