PMDA · devices & SaMD · monthly list
New and improved medical devices approved in Japan in July 2025, in English.
Last updated: 2026-09-26 · 15 approvals
PMDA lists 15 device approvals in July 2025: 5 new device(s), 1 improved device(s) with clinical data and 9 improved device(s) without clinical data; 1 are software (SaMD).
| Approved | Category | Device (brand) | Applicant | Generic name (JMDN) | Class | Approval | Review days | Use / clinical data | Source |
|---|---|---|---|---|---|---|---|---|---|
| 2025-07-30 | Improved (no clinical data) | 汎用超音波画像診断装置 LOGIQ E10s JP | GEヘルスケア・ジャパン株式会社 JP | ultrasound imaging system* 汎用超音波画像診断装置 | Class II | New approval | — | — | PMDA list |
| 2025-07-29 | New device | ClotTriever Thrombectomy System ClotTriever 血栓除去システム | Inari Medical, Inc. | Catehter for non-central circulatory embolectomy 非中心循環系塞栓除去用カテーテル | Class II | Partial change | 68 | A catheter for non-central circulatory embolectomy used to restart blood flow in patients with deep vein thrombosis with severe acute symptoms excluding post-thrombotic syndrome. The application was submitted to add... Brain/Circulatory, Respiratory, Neurology and Psychiatry · No clinical study | PMDA list |
| 2025-07-29 | Improved (no clinical data) | アバランチレーズ JP | 株式会社ジェイメック JP | neodymium YAG laser* ネオジミウム・ヤグレーザ | Class III | New approval | — | — | PMDA list |
| 2025-07-25 | Improved (no clinical data) | イントラルミナルアプリケータセット JP | 株式会社バリアンメディカルシステムズ JP | afterloading brachytherapy applicator* 非中心循環系汎用アフターローディング式ブラキセラピー装置アプリケータ | Class III | New approval | — | — | PMDA list |
| 2025-07-24 | Improved (clinical data) | シンプレラ グルコースセンサ システム JP | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | glucose monitoring system* グルコースモニタシステム | Class III | New approval | 268 | Robotics, IoT, and other devices · Foreign clinical study | PMDA list |
| 2025-07-18 | Improved (no clinical data) | オンコマイン Dx Target Test マルチ CDxシステム JP | ライフテクノロジーズジャパン株式会社 JP | somatic mutation analysis system for antineoplastic drug selection* 体細胞遺伝子変異解析システム(抗悪性腫瘍薬適応判定用) | Class III | Partial change | — | — | PMDA list |
| 2025-07-17 | New device | Cartilage Repair Device Mochi-Gel 軟骨修復材 モチジェル | Mochida Pharmaceutical Co., Ltd. 持田製薬株式会社 | Absorbable cartilage regeneration material 吸収性軟骨再生用材料 | Class IV | New approval | 778 | An absorbable cartilage regeneration material used to assist in repairing the articular cartilage damage of the knee or elbow and alleviate clinical symptoms through the repaired cartilage. Orthopedic and Plastic Surgery · Japanese clinical study | PMDA list |
| 2025-07-17 | New device | TriClip System TriClipシステム | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | Percutaneous repair system for tricuspid valve coaptation failure 経皮的三尖弁接合不全修復システム | Class IV | New approval | 352 | A percutaneous repair system for tricuspid valve coaptation failure that consists of a delivery system with a clip to coapt the tricuspid valve with regurgitation and a steerable guide catheter to deliver the... Cardiopulmonary Circulation | PMDA list |
| 2025-07-15 | New device | Esprit BTK Everolimus-Eluting Resorbable Scaffold System Esprit BTKエベロリムス溶出生体吸収性スキャフォールド | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | Bioabsorbable drug-eluting stent for lower extremity artery 薬剤溶出型吸収性下肢動脈用ステント | Class IV | New approval | 473 | A bioabsorbable drug-eluting stent for lower limb artery used to increase the intravascular lumen diameter of the below-the-knee arterial lesions in patients with chronic limb-threatening ischaemia (CLTI) (excluding... Brain/Circulatory, Respiratory, Neurology and Psychiatry · Foreign clinical study | PMDA list |
| 2025-07-15 | Improved (no clinical data) | エバーグレード ヒップシステム JP | オーソベンタス株式会社 JP | total hip replacement* 全人工股関節 | Class III | New approval | — | — | PMDA list |
| 2025-07-09 | Improved (no clinical data)SaMD | スパーク アプルーバー・ソフトウェア JP | エンビスタジャパン株式会社 JP | dental orthodontic treatment support software* 歯科矯正用治療支援プログラム | Class II | New approval | — | — | PMDA list |
| 2025-07-08 | Improved (no clinical data) | ギャラン HF JP | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | 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 |
| 2025-07-03 | New device | Peripheral Rotablator Pro ペリフェラル ロータブレーターPRO | Boston Scientific Japan K.K. ボストン・サイエンティフィックジャパン株式会社 | Atherectomy ablative angioplasty catheter アテローム切除アブレーション式血管形成術用カテーテル | Class IV | New approval | 944 | The application was submitted for the marketing approval of an atherectomy ablative angioplasty catheter to be inserted percutaneously to ablate atherosclerotic plaques and/or solid calcified below-the-knee stenotic... Brain/Circulatory, Respiratory, Neurology and Psychiatry · Japanese clinical study | PMDA list |
| 2025-07-03 | Improved (no clinical data) | ロータブレーターPRO JP | Boston Scientific Japan K.K. ボストン・サイエンティフィックジャパン株式会社 | Atherectomy ablative angioplasty catheter アテローム切除アブレーション式血管形成術用カテーテル | Class IV | Partial change | — | — | PMDA list |
| 2025-07-02 | Improved (no clinical data) | SPウイング JP | プロスパー株式会社 JP | Spinal internal fixation system 脊椎内固定器具 | Class III | 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.
Download: CSV (UTF-8). Other free lists: Japan new drug approvals · PMDA consultation fees & timelines.
Content under the Public Data License 1.0 (PDL1.0) is used under PDL1.0 (compatible with CC BY 4.0). This site edits, reorganizes and translates the original materials. The English text is an unofficial translation; the Japanese originals prevail.
This site is independent. It is not affiliated with, endorsed by, or produced by PMDA, MHLW, the Digital Agency, or any company listed. Information is provided "as is" for general information only and may be incomplete or out of date. It is not legal, regulatory or medical advice. Always check the official source before making decisions.
Last checked against official sources: .