PMDA · devices & SaMD · monthly list
New and improved medical devices approved in Japan in May 2026, in English.
Last updated: 2026-09-26 · 18 approvals
PMDA lists 18 device approvals in May 2026: 2 new device(s), 4 improved device(s) with clinical data and 12 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-05-25 | Improved (no clinical data) | Q GUIDANCEプラットフォーム JP | Stryker Japan K.K. 日本ストライカー株式会社 | neurosurgical navigation system* 脳神経外科手術用ナビゲーションユニット | Class III | New approval | — | — | PMDA list |
| 2026-05-25 | Improved (no clinical data) | Mako4ロボティックアーム JP | Stryker Japan K.K. 日本ストライカー株式会社 | robotic surgical system* 手術用ロボット手術ユニット | Class III | New approval | — | — | PMDA list |
| 2026-05-21 | Improved (no clinical data) | パワーGlide Pro ミッドラインカテーテル JP | 株式会社メディコン JP | peripheral vascular catheter* 末梢血管用血管内カテーテル | Class III | New approval | — | — | PMDA list |
| 2026-05-20 | Improved (clinical data) | Medtronic Minimed 700 Series メドトロニック ミニメド 700シリーズ | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | Portable insulin infusion pump ポータブルインスリン用輸液ポンプ | Class III | Partial change | 155 | This product is an infusion pump for portable insulin used for monitoring interstitial fluid glucose and for continuous subcutaneous administration of basal insulin at a selectable rate and for administration of a... Robotics, IoT, and other devices · Foreign clinical study | PMDA list · Review report (EN) |
| 2026-05-19 | Improved (no clinical data) | CEREGLIDE アスピレーションカテーテル JP | Johnson & Johnson K.K. ジョンソン・エンド・ジョンソン株式会社 | central circulation embolectomy catheter* 中心循環系塞栓除去用カテーテル | Class IV | Partial change | — | — | PMDA list |
| 2026-05-19 | Improved (no clinical data) | V.A.C.Ulta治療システム JP | ケーシーアイ株式会社 JP | negative pressure wound therapy system* 陰圧創傷治療システム | Class III | Partial change | — | — | PMDA list |
| 2026-05-19 | Improved (no clinical data) | バイオペックス A-Vis JP | HOYA Technosurgical株式会社 JP | artificial bone implant* 人工骨インプラント | Class III | New approval | — | — | PMDA list |
| 2026-05-19 | Improved (no clinical data) | ASP大腿骨骨端プレート JP | AUSPICIOUS株式会社 JP | Internal fixation plate 体内固定用プレート | Class III | New approval | — | — | PMDA list |
| 2026-05-15 | Improved (clinical data) | INGEVITY AFx インジェヴィティ AFx | Boston Scientific Japan Corporation ボストン・サイエンティフィックジャパン株式会社 | Implantable endocardial pacemaker electrode/lead 心内膜植込み型ペースメーカリード | Class IV | Partial change | 200 | The product is a pacemaker lead used in conjunction with implantable cardiac pacemakers and other implantable cardiac devices, and is conditionally compatible with magnetic resonance imaging (MRI) examinations only... Cardiopulmonary Circulation · Clinical evaluation report | PMDA list · Review report (EN) |
| 2026-05-14 | New device | Evolut FX+ system Evolut FX+ 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 | 142 | This product is a prosthetic cardiac valve used for transcatheter cardiac valve implantation. Cardiopulmonary Circulation · Foreign registry data | PMDA list · Review report (EN) |
| 2026-05-14 | Improved (no clinical data) | マグジール JP | メルフロンティア株式会社 JP | absorbable internal fixation screw* 吸収性体内固定用ネジ | Class IV | New approval | — | — | PMDA list |
| 2026-05-13 | Improved (clinical data) | CELECT PLATINUM IVCフィルタ JP | クックメディカルジャパン合同会社 JP | inferior vena cava filter* 下大静脈フィルタ | Class IV | New approval | 873 | Brain/Circulatory, Respiratory, Neurology and Psychiatry · Foreign clinical study | PMDA list |
| 2026-05-13 | Improved (clinical data)SaMD | Endoscopic Image Diagnostic Support Software AP01 内視鏡画像診断支援ソフトウェア AP01 | AI Medical Service Inc. 株式会社AIメディカルサービス | Supporting software for detecting lesion with endoscopic imaging 病変検出用内視鏡画像診断支援プログラム | Class II | New approval | 167 | This product is supporting software for detecting lesion with endoscopic imaging used for identifying regions suspicious for early gastric cancer or adenoma in gastric endoscopy videos and present them to physicians,... Gastroenterology, Genitourinary and Reproductive Medicine · Performance study using existing Japanese clinical data | PMDA list · Review report (EN) |
| 2026-05-13 | Improved (no clinical data) | モーゼス ファイバー 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 | single-use laser guidance probe* 単回使用レーザガイド用プローブ | Class III | New approval | — | — | PMDA list |
| 2026-05-13 | Improved (no clinical data) | サージセル・アブソーバブル・ヘモスタットMD JP | Johnson & Johnson K.K. ジョンソン・エンド・ジョンソン株式会社 | absorbable hemostatic material* 吸収性局所止血材 | Class IV | Partial change | — | — | PMDA list |
| 2026-05-07 | Improved (no clinical data) | IDENTIFY 体表面モニタリングシステム JP | 株式会社バリアンメディカルシステムズ JP | radiotherapy synchronizer* 放射線治療装置用シンクロナイザ | Class III | Partial change | — | — | PMDA list |
| 2026-05-07 | Improved (no clinical data) | Halcyon 医療用リニアック JP | 株式会社バリアンメディカルシステムズ JP | linear accelerator system* 線形加速器システム | Class III | Partial change | — | — | PMDA list |
| 2026-05-01 | New device | アヴェイル LP JP | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | Implantable leadless cardiac pacemaker 植込み型リードレス心臓ペースメーカ | Class IV | Partial change | 44 | Cardiopulmonary Circulation · No clinical study | 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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