PMDA · devices & SaMD · monthly list
New and improved medical devices approved in Japan in May 2025, in English.
Last updated: 2026-09-26 · 12 approvals
PMDA lists 12 device approvals in May 2025: 1 new device(s), 1 improved device(s) with clinical data and 10 improved device(s) without clinical data.
| Approved | Category | Device (brand) | Applicant | Generic name (JMDN) | Class | Approval | Review days | Use / clinical data | Source |
|---|---|---|---|---|---|---|---|---|---|
| 2025-05-27 | Improved (no clinical data) | パワーシール JP | Olympus Medical Systems Corp. オリンパスメディカルシステムズ株式会社 | active therapeutic instrument* 治療用能動器具 | Class III | Partial change | — | — | PMDA list |
| 2025-05-22 | Improved (clinical data) | AviClear レーザシステム JP | キュテラ株式会社 JP | Diode laser ダイオードレーザ | Class III | New approval | 828 | Orthopedic and Plastic Surgery · Foreign clinical study | PMDA list |
| 2025-05-21 | Improved (no clinical data) | SANAPGA縫合糸 JP | ジェネシス・メドテック・ジャパン株式会社 JP | polyglycolic acid suture* ポリグリコール酸縫合糸 | Class IV | New approval | — | — | PMDA list |
| 2025-05-21 | Improved (no clinical data) | HOYA Vivinex トーリック JP | HOYA Corporation HOYA株式会社 | posterior chamber intraocular lens with injector* 挿入器付後房レンズ | Class III | Partial change | — | — | PMDA list |
| 2025-05-20 | Improved (no clinical data) | AtriCure ダイセクター JP | センチュリーメディカル株式会社 JP | single-use retractor* 単回使用開創器 | Class II | Partial change | — | — | PMDA list |
| 2025-05-20 | Improved (no clinical data) | ScoreFlex QUAD スリッピング防止型バルーン JP | オーバスネイチメディカル株式会社 JP | Catheter for coronary balloon dilatation angioplasty 冠血管向けバルーン拡張式血管形成術用カテーテル | Class IV | New approval | — | — | PMDA list |
| 2025-05-19 | Improved (no clinical data) | CSPワイヤリングシステム(Ti) JP | 株式会社ホムズ技研 JP | internal fixation cable* 体内固定用ケーブル | Class III | Partial change | — | — | PMDA list |
| 2025-05-12 | 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 | 87 | A transcatheter porcine pericardial valve used for transcatheter aortic valve implantation. The application was submitted to add a raw material used as an additive of the inner liner of the delivery catheter system,... Cardiopulmonary Circulation · No clinical study | PMDA list |
| 2025-05-12 | Improved (no clinical data) | オムニオックス 75HL JP | アイ・エム・アイ株式会社 JP | bilevel positive airway pressure device* 二相式気道陽圧ユニット | Class III | New approval | — | — | PMDA list |
| 2025-05-08 | Improved (no clinical data) | TruSight Oncology Comprehensive パネルシステム JP | イルミナ株式会社 JP | cancer genome profiling analysis kit* 遺伝子変異解析セット(がんゲノムプロファイリング検査用) | Class III | New approval | — | — | PMDA list |
| 2025-05-08 | Improved (no clinical data) | FiberStitch RC System† FiberStitch RCシステム | Arthrex Japan合同会社 JP | implantable suture anchor* 植込み型縫合糸固定用具 | Class III | New approval | — | — | PMDA list |
| 2025-05-02 | Improved (no clinical data) | マックスタック JP | Covidien Japan Inc. コヴィディエンジャパン株式会社 | absorbable internal fixation tissue staple* 吸収性体内固定用組織ステープル | Class IV | 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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