PMDA · devices & SaMD · monthly list
New and improved medical devices approved in Japan in June 2025, in English.
Last updated: 2026-09-26 · 29 approvals
PMDA lists 29 device approvals in June 2025: 5 new device(s), 5 improved device(s) with clinical data and 19 improved device(s) without clinical data; 4 are software (SaMD).
| Approved | Category | Device (brand) | Applicant | Generic name (JMDN) | Class | Approval | Review days | Use / clinical data | Source |
|---|---|---|---|---|---|---|---|---|---|
| 2025-06-30 | Improved (no clinical data) | T.REXSPINE Laminoplasty System† T.REXSPINE Laminoplasty システム | 株式会社 オーミック JP | Spinal internal fixation system 脊椎内固定器具 | Class III | New approval | — | — | PMDA list |
| 2025-06-26 | 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 | New approval | 300 | 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 · Foreign clinical study | PMDA list |
| 2025-06-26 | 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 | New approval | 300 | A generator of a radiofrequency and pulsed energy is intended for percutaneous myocardial catheter ablation. (The original product is in the post-market performance review period.) Cardiopulmonary Circulation · Foreign clinical study | PMDA list |
| 2025-06-26 | Improved (no clinical data) | シブコ経食道超音波プローブ消毒器ASTRA TEE JP | センチュリーメディカル株式会社 JP | ultrasound probe cleaner disinfector* 超音波診断用プローブ用洗浄消毒器 | Class II | New approval | — | — | PMDA list |
| 2025-06-26 | Improved (no clinical data) | MectaLIF Posterior 3D ケージ JP | メダクタジャパン株式会社 JP | Spinal cage 脊椎ケージ | Class III | New approval | — | — | PMDA list |
| 2025-06-23 | New device | Jetstream Atherectomy System ジェットストリーム アテレクトミー システム | 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 | 74 | An atherectomy ablation angioplasty catheter composed of a catheter set that is percutaneously inserted into the peripheral blood vessel to cut, crush, and suck the lesion by rotating the tip of the catheter and a... Brain/Circulatory, Respiratory, Neurology and Psychiatry · No clinical study | PMDA list |
| 2025-06-23 | Improved (clinical data)SaMD | リモハブ CR U JP | 株式会社リモハブ JP | cardiac stress testing analysis software* 解析機能付き心臓運動負荷モニタリングシステム用プログラム | Class III | New approval | 294 | Program (SaMD) · Japanese clinical study | PMDA list |
| 2025-06-19 | New device | Visual-ICE Cryoablation System 冷凍手術器 Visual-ICE | 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 | General-purpose cryosurgical unit 汎用冷凍手術ユニット | Class III | Partial change | 267 | A cryosurgical unit composed of the device main body that generates low temperature, etc., a needle that is inserted to freeze and necrotize the target tissue, and a multipoint temperature sensor that detects the... Gastroenterology, Genitourinary and Reproductive Medicine · Japanese clinical study | PMDA list |
| 2025-06-19 | Improved (no clinical data) | EIT System Enlight 2100† EITシステム Enlight 2100 | TIMPEL S.A. | electrical impedance scanner* 電気インピーダンススキャナ | Class II | Partial change | — | — | PMDA list |
| 2025-06-19 | Improved (no clinical data) | サンダービートII JP | Olympus Medical Systems Corp. オリンパスメディカルシステムズ株式会社 | multi-energy therapeutic instrument* 複数エネルギー処置用能動器具 | Class III | New approval | — | — | PMDA list |
| 2025-06-17 | Improved (no clinical data)SaMD | HOPE LifeMark-類似画像症例検索支援システム for びまん性肺疾患 JP | 富士通Japan株式会社 JP | X-ray diagnostic imaging workstation software* X線画像診断装置ワークステーション用プログラム | Class II | New approval | — | — | PMDA list |
| 2025-06-17 | Improved (no clinical data) | Force Feedback用 インストゥルメント JP | インテュイティブサージカル合同会社 JP | reusable endoscopic active instrument* 再使用可能な内視鏡用能動処置具 | Class II | Partial change | — | — | PMDA list |
| 2025-06-17 | Improved (no clinical data) | トップリージョンジェネレーター TLG-20 JP | 株式会社トップ JP | ablation electrosurgical unit* 焼灼術用電気手術ユニット | Class III | Partial change | — | — | PMDA list |
| 2025-06-13 | Improved (no clinical data) | ASD閉鎖セット JP | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | Artificial pericardial prosthesis 人工心膜用補綴材 | Class IV | Partial change | — | — | PMDA list |
| 2025-06-13 | Improved (no clinical data) | ポール緑内障インプラント JP | 株式会社トーメーコーポレーション JP | intraocular drain* 眼内ドレーン | Class III | New approval | — | — | PMDA list |
| 2025-06-12 | Improved (clinical data) | アルティペース JP | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | implantable pacemaker defibrillator lead* 植込み型除細動器・ペースメーカリード | Class IV | Partial change | 119 | Cardiopulmonary Circulation · Clinical evaluation report | PMDA list |
| 2025-06-12 | Improved (clinical data)SaMD | オートキャスFFR JP | Medhub Ltd. | Analyzing software for hemodynamics or cardiac function 循環動態解析プログラム | Class II | New approval | 470 | Program (SaMD) · Performance study using existing foreign clinical data | PMDA list |
| 2025-06-12 | Improved (no clinical data)SaMD | 医用画像解析ソフトウェア EIRL aneurysm JP | LPIXEL Inc. エルピクセル株式会社 | magnetic resonance device workstation software* MR装置ワークステーション用プログラム | Class II | Partial change | — | — | PMDA list |
| 2025-06-10 | Improved (no clinical data) | Afferaマッピングシステム JP | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | cardiac catheter testing device* 心臓カテーテル用検査装置 | Class III | New approval | — | — | PMDA list |
| 2025-06-10 | Improved (no clinical data) | Mixed Reality ナビゲーション JP | ブレインラボ株式会社 JP | surgical navigation system* 手術用ナビゲーションユニット | Class II | New approval | — | — | PMDA list |
| 2025-06-09 | Improved (no clinical data) | IB3Dスパイナルシステム JP | メドトロニックソファモアダネック株式会社 JP | Spinal cage 脊椎ケージ | Class III | New approval | — | — | PMDA list |
| 2025-06-06 | New device | UroLift System UroLift システム | NeoTract, Inc. | Implantable prostatic tissue retractor system 植込み型前立腺組織牽引システム | Class III | Partial change | 80 | An implantable prostate tissue retractor system indicated for the treatment of dysuria associated with prostatic hyperplasia. The system is composed of an implant to be placed in the prostate and a delivery device... Gastroenterology, Genitourinary and Reproductive Medicine · No clinical study | PMDA list |
| 2025-06-06 | Improved (no clinical data) | 血液ガス検体採血用シリンジ safePICO A JP | ラジオメーター株式会社 JP | blood gas analysis syringe* 血液ガス検体採取用注射筒 | Class II | New approval | — | — | PMDA list |
| 2025-06-05 | Improved (clinical data) | PTeye System† PTeyeシステム | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | autofluorescence imaging system* 自家蛍光検出装置 | Class II | New approval | 268 | Robotics, IoT, and other devices · Clinical evaluation report | PMDA list |
| 2025-06-05 | Improved (clinical data) | ベンタナ DP200 Dxシステム JP | ロシュ・ダイアグノスティックス株式会社 JP | Diagnostic assistant device for pathological whole slide image 病理ホールスライド画像診断補助装置 | Class II | New approval | 266 | Robotics, IoT, and other devices · Clinical evaluation report | PMDA list |
| 2025-06-05 | Improved (no clinical data) | ゴア TIPS セット JP | W. L. Gore & Associates G.K. 日本ゴア合同会社 | transjugular intrahepatic portosystemic shunt set* 経頸静脈肝内門脈アクセスセット | Class III | New approval | — | — | PMDA list |
| 2025-06-05 | Improved (no clinical data) | LOCKADOクリップ JP | エム・シー・メディカル株式会社 JP | implantable closure clip* 体内用結さつクリップ | Class III | New approval | — | — | PMDA list |
| 2025-06-04 | Improved (no clinical data) | Univers Revers人工肩関節 JP | Arthrex Japan合同会社 JP | total shoulder replacement* 全人工肩関節 | Class III | New approval | — | — | PMDA list |
| 2025-06-04 | Improved (no clinical data) | Univers Revers人工肩関節Monoblock JP | Arthrex Japan合同会社 JP | Shoulder prosthesis humeral component 人工肩関節上腕骨コンポーネント | 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.
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