The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.
The review reports were selected for translation among those of new medical devices that recently received marketing approval, in consideration of relevant factors including the novelty and priority.
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| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Absorb GT1 Bioresorbable Vascular Scaffold System | Bio-absorbable coronary stent | November 2016 | English [838.15 KB] | Japanese [11.75 MB] |
| Adacolumn | Leukocytapheresis device | June 2012 | English [175.87 KB] | Japanese [330.93 KB] |
| AutoloGel System | Platelet-rich plasma gel preparation kit | November 2022 | English [692.40 KB] | Japanese No.1 [4.59 MB] Japanese No.2 [7.00 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| C2 Coronary IVL Catheter | Atherectomy ablative angioplasty catheter | March 2022 | English [670.29 KB] | Japanese [1.74 MB] |
| Celution Cell Therapy Kit SUI | Adipose tissue separation kit | February 2022 | English [1.23 MB] | Japanese [6.35 MB] |
| Cool-tip RFA System E Series | Radiofrequency ablation system | July 2018 | English [628 .94 KB] |
Japanese [644.06 KB] |
| CureApp HT Digital Therapeutic App for Hypertension Adjunctive Treatment | Supporting software for hypertension treatment | April 2022 | English [658.62 KB] | Japanese [4.96 MB] |
| CureApp SC Digital Therapeutic and CO Checker for Nicotine Dependence | Smoking cessation treatment support system | August 2020 | English [857.50 KB] | Japanese [808.47 KB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Duolith SD1 Ultra Partial Change Approval |
Extracorporeal shockwave skin ulcer treatment device | December 2022 | English [508.62 KB] | Japanese [2.68 MB] |
| DuraHeart Left Ventricular Assist System | Implantable ventricular assist device | December 2010 | English [373.54 KB] | Japanese [5.13 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| EC-PDT Probe | Single-use probe for PDT semiconductor laser | May 2015 | English [1.13 MB] | Japanese No.1 [63.65 KB] Japanese No.2 [698.78 KB] |
| Edwards SAPIEN 3 Partial Change Approval |
Transcatheter bovine cardiac valve | September 2022 | English [951.33 KB] | Japanese [2.11 MB] |
| EluNIR Drug-Eluting Stent | Coronary stent | October 2021 | English [669.95 KB] | Japanese [1.06 MB] |
| Endeavor Coronary Stent System | Coronary stent | March 2009 | English [310.97 KB] | Japanese [1.49 MB] |
| ENROUTE Transcarotid Neuroprotection System | Catheter for embolic capture in the central circulation system | October 2022 | English [710.54 KB] | Japanese No.1 [2.23 MB] Japanese No.2 [9.35 MB] |
| Espline SARS-CoV-2(Note 2) | SARS-CoV-2 antigen kit (IVD) | May 2020 | English [208.43 KB] | Japanese [88.89 KB] |
| Eustachian Tube Plug | Prosthetic material for eustachian tube | May 2020 | English [830.39 KB] | Japanese [1000.82 KB] |
Note 2 Review Summary
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Fetal Shunt | Shunt for fetal pleural effusion | November 2011 | English [163.10 KB] | Japanese [633.10 KB] |
| FoundationOne CDx Cancer Genomic Profile | Software for gene variants analysis (for comprehensive genomic profiling for cancer) Software for analysis of somatic variants (for eligibility identification of antineoplastic agents) |
December 2018 | English [410.20 KB] | Japanese [2.68 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| GORE TAG Thoracic Aortic Stent Graft System | Aortic stent grafts | March 2008 | English [331.02 KB] | Japanese [3.01 MB] |
| Gore Viabahn Stent Graft | Heparin-coated stent-graft for central circulatory system heparin-coated stent-graft for blood vessels |
February 2016 | English [616.16 KB] | Japanese [8.04 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| HAL for Medical Use (Lower Limb Type) | Biosignal-responsive motor function improvement device | November 2015 | English [10.25 MB] | Japanese No.1 [9.64 MB] Japanese No.2 [9.58 MB] Japanese No.3 [10.25 MB] Errata sheet (JP) [33.67 KB](Note 1) |
| Harmony Transcatheter Pulmonary Valve Replacement System | Transcatheter porcine pericardial valve | August 2021 | English [1.02 MB] | Japanese [5.00 MB] |
Note 1 The English translation has been corrected accordingly.
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Implantable Ventricular Assist System EVAHEART | Implantable ventricular assist device | December 2010 | English [380.80 KB] | Japanese No.1 [916.29 KB] Japanese No.2 [869.65 KB] Japanese No.3 [835.58 KB] Japanese No.4 [498.45 KB] |
| IVL Generator | Driving unit for atherectomy angioplasty catheter | March 2022 | English [670.38 KB] | Japanese [1.74 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Jarvik 2000 Implantable Ventricular Assist Device | Implantable ventricular assist device | November 2013 | English [411.49 KB] | Japanese [1.29 MB] Errata sheet (JP) [84.17 KB](Note 1) |
Note 1 The English translation has been corrected accordingly.
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Kawasumi Najuta Thoracic Stent Graft System | Aortic stent graft | December 2012 | English [1.42 MB] | Japanese [755.81 KB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Matsudaito | Non-absorbable local hemostatic material for central circulation system | December 2011 | English [658.93 KB] | Japanese No.1 [8.77 MB] Japanese No.2 [10.84 MB] |
| Medtronic Percept PC Partial Change Approval |
Tremor brain electrical stimulator | July 2023 | English [1.13 MB] | Japanese [3.20 MB] |
| MitraClip NT System | Percutaneous repair system for mitral valve coaptation failure | October 2017 | English [1.01 MB] | Japanese [2.82 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Nerve Regeneration Guidance Conduit Nerbridge | Collagen-containing absorbable nerve regeneration inducing material | March 2013 | English [273.29 KB] | Japanese [650.21 KB] |
| NeuCure BNCT Dose Engine | Treatment planning program for boron neutron capture therapy | March 2020 | English [2.31 MB] | Japanese [2.54 MB] |
| NeuCure BNCT System | Neutron irradiation system for boron neutron capture therapy | March 2020 | English [2.31 MB] | Japanese [2.53 MB] |
| nodoca | Endoscopic telescope disease characteristic finding detection support software for endoscope |
April 2022 | English [841.19 KB] | Japanese [4.50 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| OncoGuide NCC Oncopanel System | Gene variants analysis set (for comprehensive genomic profiling for cancer) | December 2018 | English [254.23 KB] | Japanese [520.11 KB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| PD Laser Partial Change Approval |
PDT semiconductor laser | May 2015 | English [1.13 MB] | Japanese No.1 [63.65 KB] Japanese No.2 [698.78 KB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| RETISSA Medical | Laser retinal scanning type eyewear | January 2020 | English [1.09 MB] | Japanese [1.21 MB] |
| RFA System | Radiofrequency ablation system | July 2018 | English [593.61 KB] | Japanese [10.40 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| SATAKE-HotBalloon Catheter | Cardiac ablation catheter | November 2015 | English [535.72 KB] | Japanese [6.17 MB] |
| Suncon Kyoto-CS | Limbal-supported contact lens for abnormal corneal shape | February 2016 | English [593.74 KB] | Japanese [737.03 KB] |
| SUSMED Med CBT-i App for Insomnia | Software for insomnia | February 2023 | English [767.20 KB] | Japanese [1.75 MB] |
| Synfolium | Synthetic myocardial patch | July 2023 | English [535.01 KB] | Japanese [2.03 MB] |
| Syringe Pump Control Software for Assisting Total Intravenous Anesthesia | Software for automated drug delivery for general anesthesia | September 2022 | English [625.56 KB] | Japanese [2.62 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| TITANBRIDGE | Thyroid cartilage fixation device | December 2017 | English [463.81 KB] | Japanese [766.77 KB] |
| TRUPULSE Generator | Percutaneous cardiac coagulation/ablation electrosurgical unit | December 2023 | English [1.03 MB] | Japanese [5.37 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| VARIPULSE Pulsed Field Ablation Catheter | Cardiac ablation catheter | December 2023 | English [1.03 MB] | Japanese [5.36 MB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Wingspan Stent System | Cerebral artery stent | November 2013 | English [380.81 KB] | Japanese [610.55 KB] |
| Brand Name | Term Name | Approved In | Review Report (EN) | Review Report (JP) |
|---|---|---|---|---|
| Zephyr Endobronchial Valve System | Endobronchial valve | November 2022 | English [1.36 MB] | Japanese [1.47 MB] |
| Zilver Vena Venous Stent | Venous stent | December 2022 | English [1.17 MB] | Japanese [8.81 MB] |