PMDA · devices & SaMD · monthly list
New and improved medical devices approved in Japan in October 2025, in English.
Last updated: 2026-09-26 · 28 approvals
PMDA lists 28 device approvals in October 2025: 5 new device(s), 4 improved device(s) with clinical data and 19 improved device(s) without clinical data; 3 are software (SaMD).
| Approved | Category | Device (brand) | Applicant | Generic name (JMDN) | Class | Approval | Review days | Use / clinical data | Source |
|---|---|---|---|---|---|---|---|---|---|
| 2025-10-31 | Improved (clinical data) | レスチレン ディファイン JP | ガルデルマ株式会社 JP | hyaluronic acid soft tissue filler* ヒアルロン酸使用軟組織注入材 | Class IV | New approval | 612 | Orthopedic and Plastic Surgery · Foreign clinical study | PMDA list |
| 2025-10-31 | Improved (clinical data) | レスチレン リファイン JP | ガルデルマ株式会社 JP | hyaluronic acid soft tissue filler* ヒアルロン酸使用軟組織注入材 | Class IV | New approval | 582 | Orthopedic and Plastic Surgery · Foreign clinical study | PMDA list |
| 2025-10-29 | Improved (no clinical data) | ダイセルインジェクターP1 SC JP | 株式会社ダイセルメディカル JP | gas-powered needle-free drug and vaccine injector* ガス式針なし医薬品・ワクチン用注入器 | Class II | New approval | — | — | PMDA list |
| 2025-10-29 | Improved (no clinical data) | リヴァコア 7 CRT-D ProMRI JP | バイオトロニックジャパン株式会社 JP | implantable biventricular pacemaker defibrillator* 除細動機能付植込み型両心室ペーシングパルスジェネレータ | Class IV | Partial change | — | — | PMDA list |
| 2025-10-29 | Improved (no clinical data) | アサート IQ JP | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | implantable cardiac event monitor* 植込み型心電用データレコーダ | Class IV | Partial change | — | — | PMDA list |
| 2025-10-29 | Improved (no clinical data) | 電気刺激装置/筋電計 KR-6222 JP | オージー技研株式会社 JP | gait assist neuromuscular stimulation device* 歩行神経筋電気刺激装置 | Class II | New approval | — | — | PMDA list |
| 2025-10-24 | New device | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis ゴア エクスクルーダー 胸腹部大動脈ブランチ型ステントグラフトシステム | W. L. Gore & Associates G.K. 日本ゴア合同会社 | Aortic stent graft 大動脈用ステントグラフト | Class IV | Partial change | 98 | An aortic stent graft system used for the treatment of patients with thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms who are difficult to treat with conventional surgical repair. The... Brain/Circulatory, Respiratory, Neurology and Psychiatry · No clinical study | PMDA list |
| 2025-10-23 | Improved (no clinical data)SaMD | Guardant360 CDx がん遺伝子パネル JP | ガーダントヘルスジャパン株式会社 JP | Gene mutation analysis program (for cancer genome profiling) 遺伝子変異解析プログラム(がんゲノムプロファイリング検査用) | Class III | Partial change | — | — | PMDA list |
| 2025-10-23 | Improved (no clinical data) | 白内障・硝子体手術装置 QUATERA 700 JP | Carl Zeiss Meditech Co., Ltd. カールツァイスメディテック株式会社 | cataract vitrectomy system* 白内障・硝子体手術装置 | Class III | New approval | — | — | PMDA list |
| 2025-10-23 | Improved (no clinical data) | Hugo LigaSureインストゥルメント JP | Covidien Japan Inc. コヴィディエンジャパン株式会社 | active therapeutic instrument* 治療用能動器具 | Class III | New approval | — | — | PMDA list |
| 2025-10-23 | Improved (no clinical data) | U2 PF+トータルニーCRシステム JP | ユナイテッド・オーソペディック・ジャパン株式会社 JP | total knee replacement* 全人工膝関節 | Class III | New approval | — | — | PMDA list |
| 2025-10-22 | Improved (clinical data) | LVIS EVO Stent† LVIS EVOステント | Terumo Corporation テルモ株式会社 | Central circulatory intravascular embolization prosthesis 中心循環系血管内塞栓促進用補綴材 | Class IV | New approval | 209 | Brain/Circulatory, Respiratory, Neurology and Psychiatry · Japanese clinical study | PMDA list |
| 2025-10-22 | Improved (no clinical data) | AtriCure左心耳クリップMiniタイプ JP | センチュリーメディカル株式会社 JP | cardiac tissue clip* 心臓組織用クリップ | Class IV | New approval | — | — | PMDA list |
| 2025-10-20 | New device | DUOLITH SD1 Ultra デュオリスSD1ウルトラ | Storz Medical Japan Co.,Ltd. ストルツメディカル・ジャパン株式会社 | Extracorporeal shockwave pain treatment device 体外衝撃波疼痛治療装置 | Class III | Partial change | 73 | An extracorporeal shockwave pain treatment device is used for pain relief in patients with refractory plantar aponeurositis and for the treatment of refractory ulcer in patients with systemic scleroderma. The... Orthopedic and Plastic Surgery · No clinical study | PMDA list |
| 2025-10-20 | New device | Sphere-9 Catheter Sphere-9カテーテル | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | Catheter for cardiac ablation アブレーション向け循環器用カテーテル | Class IV | Partial change | 88 | An ablation catheter for cardiac electrophysiological mapping as well as the treatments of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, drug refractory symptomatic persistent atrial... Cardiopulmonary Circulation · No clinical study | PMDA list |
| 2025-10-20 | Improved (no clinical data) | ライフパック35 JP | Stryker Japan K.K. 日本ストライカー株式会社 | temporary pacing defibrillator* 一時的使用ペーシング機能付除細動器 | Class III | New approval | — | — | PMDA list |
| 2025-10-14 | Improved (no clinical data) | CARESCAPETM ベッドサイドモニタ B850 JP | GEヘルスケア・ジャパン株式会社 JP | Multi-parameter patient monitor with critical parameters 重要パラメータ付き多項目モニタ | Class III | New approval | — | — | PMDA list |
| 2025-10-08 | New device | Affera Ablation System Afferaアブレーションシステム | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | Percutaneous cardiac coagulation/ablation electrosurgical unit 経皮心筋焼灼術用電気手術ユニット | Class III | Partial change | 55 | A generator of a radiofrequency and pulsed energy is intended for percutaneous myocardial catheter ablation. The application was submitted to add a manufacturing site. (A “partial change” application submitted during... Cardiopulmonary Circulation · No clinical study | PMDA list |
| 2025-10-08 | Improved (no clinical data) | オーパスウェーブ JP | Terumo Corporation テルモ株式会社 | optical coherence tomography diagnostic imaging device* OCT画像診断装置 | Class II | New approval | — | — | PMDA list |
| 2025-10-08 | Improved (no clinical data) | デュアルビュー JP | Terumo Corporation テルモ株式会社 | intravascular optical coherence tomography catheter* 血管内光断層撮影用カテーテル | Class IV | New approval | — | — | PMDA list |
| 2025-10-03 | Improved (no clinical data)SaMD | FoundationOne CDx がんゲノムプロファイル JP | 中外製薬株式会社 JP | Gene mutation analysis program (for cancer genome profiling) 遺伝子変異解析プログラム(がんゲノムプロファイリング検査用) | Class III | Partial change | — | — | PMDA list |
| 2025-10-03 | Improved (no clinical data) | モフィウスプロ JP | インモード・ジャパン株式会社 JP | electrosurgical unit* 治療用電気手術器 | Class III | New approval | — | — | PMDA list |
| 2025-10-02 | Improved (clinical data) | nodoca(ノドカ) JP | アイリス株式会社 JP | endoscopic telescope* 内視鏡用テレスコープ | Class II | Partial change | 279 | Robotics, IoT, and other devices · Japanese clinical study | PMDA list |
| 2025-10-02 | Improved (no clinical data) | Gold Anchor イントロデューサー JP | GAジャパンカンパニー合同会社 JP | implantable lesion identification marker* 植込み型病変識別マーカ | Class III | New approval | — | — | PMDA list |
| 2025-10-02 | Improved (no clinical data) | Q-FIX Knotless Anchor† Q-FIX Knotless アンカー | スミス・アンド・ネフュー株式会社 JP | ligament fixation device* 靱帯固定具 | — | New approval | — | — | PMDA list |
| 2025-10-01 | New device | Evolut PRO+ System Evolut PRO+ システム | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | Transcatheter porcine pericardial valve 経カテーテルブタ心のう膜弁 | Class IV | Partial change | 299 | A prosthetic cardiac valve system used for transcatheter valve implantation. The system mainly consists of a porcine pericardium-derived bioprosthetic valve and a delivery catheter system that is used to deploy the... Cardiopulmonary Circulation · Foreign registry data | PMDA list |
| 2025-10-01 | Improved (no clinical data)SaMD | 眼底画像AI診断支援プログラム RA-100 JP | 合同会社G-Data JP | fundus camera software* 眼底カメラ用プログラム | Class II | New approval | — | — | PMDA list |
| 2025-10-01 | Improved (no clinical data) | ポケットオーラルエコー HD-1 JP | 株式会社デントロケミカル JP | ultrasound imaging system* 汎用超音波画像診断装置 | Class II | New approval | — | — | PMDA list |
Click a column header to sort. JP = no official English name published; Japanese kept. * = machine-translated generic name (not verified). † = brand romanised from Japanese, not an official English name. Class = Japanese risk class (I–IV). Review days = PMDA total review time, published for new devices and improved devices with clinical data only.
Source: PMDA / MHLW (PDL1.0). Unofficial English translation, edited by Japan Pharma Regulatory Brief.
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