PMDA · devices & SaMD · monthly list
New and improved medical devices approved in Japan in February 2026, in English.
Last updated: 2026-09-26 · 33 approvals
PMDA lists 33 device approvals in February 2026: 3 new device(s), 9 improved device(s) with clinical data and 21 improved device(s) without clinical data; 6 are software (SaMD).
| Approved | Category | Device (brand) | Applicant | Generic name (JMDN) | Class | Approval | Review days | Use / clinical data | Source |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-27 | 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 |
| 2026-02-27 | Improved (no clinical data) | Stellar M22 IPLモデル JP | ルミナス・ビー・ジャパン株式会社 JP | xenon light therapy device* キセノン光線治療器 | Class II | Partial change | — | — | PMDA list |
| 2026-02-26 | Improved (no clinical data) | Joline BKP System† Joline BKP システム | 株式会社ロバート・リード商会 JP | single-use vertebral correction instrument* 単回使用椎体用矯正器具 | Class II | New approval | — | — | PMDA list |
| 2026-02-25 | Improved (clinical data) | Transcend PEEK LIF cage/AMP plate Transcend PEEK LIFケージ/AMPプレート | Alphatec Spine, Inc. | Spinal cage 脊椎ケージ | Class III | Partial change | 260 | The purpose of this application is to allow lateral interbody fusion to be performed on patients in the prone position (hereinafter referred to as "prone LIF") when using the lumbar, while lateral interbody fusion... Orthopedic and Plastic Surgery · Clinical evaluation report | PMDA list · Review report (EN) |
| 2026-02-24 | New device | Alpha DaRT System† Alpha DaRT システム | Alpha Tau Medical Ltd. | Radiation source for manual brachytherapy (non-central circulatory, temporary) 非中心循環系一時留置向け手動式ブラキセラピー装置用放射線源 | Class III | New approval | 830 | Robotics, IoT, and other devices · Japanese clinical study | PMDA list |
| 2026-02-24 | New device | エピフィックス (EpiFix) JP | MiMedx Group, Inc. | Human amnion-based wound healing material ヒト羊膜使用組織治癒促進用材料 | Class IV | Partial change | 118 | Orthopedic and Plastic Surgery · No clinical study | PMDA list |
| 2026-02-24 | Improved (no clinical data)SaMD | 口腔粘膜画像解析システム Mucosight AI JP | 株式会社モリタ東京製作所 JP | intraoral lesion detection software* 病変検出用口腔内画像診断支援プログラム | Class II | New approval | — | — | PMDA list |
| 2026-02-20 | Improved (no clinical data)SaMD | 医用画像解析ソフトウェア EIRL Surgery LC JP | LPIXEL Inc. エルピクセル株式会社 | Surgical image recognition support program 手術用画像認識支援プログラム | Class II | New approval | — | — | PMDA list |
| 2026-02-19 | Improved (clinical data) | E1000 Dx Digital Pathology Solution E1000 Dx デジタルパソロジーソリューション | PHC Corporation PHC株式会社 | 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 | 265 | This product is a diagnostic assistant device for pathological whole slide image used for assisting pathologists in evaluation and diagnosis through creation, storage and display of high magnification images of whole... Robotics, IoT, and other devices · Clinical evaluation report | PMDA list · Review report (EN) |
| 2026-02-19 | Improved (clinical data) | Peripheral Orbital Atherectomy System Peripheral Orbital Atherectomy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 | 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 | 267 | The product is an atherectomy ablative angioplasty catheter that is percutaneously inserted into peripheral vessels and removes calcified lesions by rotating the catheter distal portion. Brain/Circulatory, Respiratory, Neurology and Psychiatry · Japanese clinical study | PMDA list · Review report (EN) |
| 2026-02-19 | Improved (clinical data) | Agent paclitaxel-coated balloon catheter Agent パクリタキセルコーティッド バルーンカテーテル | 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 | 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 | Partial change | 195 | The product is a catheter for coronary balloon dilatation angioplasty used to inhibit restenosis during revascularization of coronary stent restenosis and de novo coronary artery lesions. Cardiopulmonary Circulation · Japanese registry data | PMDA list · Review report (EN) |
| 2026-02-19 | Improved (no clinical data) | SMR セメントレス ショートステム JP | エノヴィスジャパン株式会社 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 |
| 2026-02-18 | Improved (no clinical data) | Elekta Evo リニアックシステム JP | エレクタ株式会社 JP | linear accelerator system* 線形加速器システム | Class III | New approval | — | — | PMDA list |
| 2026-02-16 | Improved (no clinical data) | ProCinch靱帯再建システム JP | Stryker Japan K.K. 日本ストライカー株式会社 | ligament fixation device* 靱帯固定具 | — | New approval | — | — | PMDA list |
| 2026-02-16 | Improved (no clinical data)SaMD | チェアサイドソフトウエア L-CAD JP | Huvitz Co.,Ltd. | Dental restoration design support program 歯科修復物設計支援プログラム | Class II | New approval | — | — | PMDA list |
| 2026-02-16 | Improved (no clinical data) | EndoWrist 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 |
| 2026-02-13 | Improved (clinical data) | Verte ヴァーテ | Menicon Co., Ltd. 株式会社メニコン | Absorbable bone regeneration material 吸収性骨再生用材料 | Class IV | New approval | 252 | The product is an absorbable bone regeneration material that assists bone regeneration by mixing with autologous bone and implanting in bone defects. Orthopedic and Plastic Surgery · Japanese clinical study | PMDA list · Review report (EN) |
| 2026-02-13 | Improved (no clinical data) | Pisces DOUBLE TULIP コネクター JP | 株式会社日本エム・ディ・エム JP | Spinal internal fixation system 脊椎内固定器具 | Class III | New approval | — | — | PMDA list |
| 2026-02-12 | Improved (no clinical data)SaMD | MyChoice診断システム JP | Myriad Genetic Laboratories, Inc. | Somatic gene mutation analysis program (for anticancer drug eligibility) 体細胞遺伝子変異解析プログラム(抗悪性腫瘍薬適応判定用) | Class III | Partial change | — | — | PMDA list |
| 2026-02-12 | Improved (no clinical data)SaMD | CoroFlowカーディオバスキュラー システム JP | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | invasive blood pressure monitoring software* 観血血圧モニタ用プログラム | Class II | Partial change | — | — | PMDA list |
| 2026-02-12 | Improved (no clinical data) | Veffecta Wrist System† Veffecta Wrist システム | 株式会社エム・イー・システム JP | Internal fixation plate 体内固定用プレート | Class III | Partial change | — | — | PMDA list |
| 2026-02-12 | Improved (no clinical data)SaMD | 画像診断支援ソフトウェア KDSS-PTX-AI JP | コニカミノルタ株式会社 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 |
| 2026-02-10 | Improved (no clinical data) | ニプロ血栓吸引カテーテルS JP | 株式会社グッドマン JP | central circulation embolectomy catheter* 中心循環系塞栓除去用カテーテル | Class IV | New approval | — | — | PMDA list |
| 2026-02-06 | New device | TRUPULSEジェネレータ JP | ジョンソン・エンド・ジョンソン株式社 JP | 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 | 79 | Cardiopulmonary Circulation · No clinical study | PMDA list |
| 2026-02-04 | Improved (clinical data) | ティクセルi JP | Novoxel Japan株式会社 JP | eyelid warmer* 眼瞼加温加圧装置 | Class II | New approval | 392 | Ophthalmology and Otorhinolaryngology · Foreign clinical study | PMDA list |
| 2026-02-04 | Improved (no clinical data) | フラッシュポンプ JP | 株式会社エスケーエレクトロニクス JP | pressurized drug injector* 加圧式医薬品注入器 | Class III | New approval | — | — | PMDA list |
| 2026-02-04 | Improved (no clinical data) | Univers Revers人工肩関節MGS Augment JP | Arthrex Japan合同会社 JP | shoulder joint replacement glenoid component* 人工肩関節関節窩コンポーネント | Class III | New approval | — | — | PMDA list |
| 2026-02-03 | Improved (clinical data) | Leica Aperio GT450 DX ライカ Aperio GT 450 DX | Leica Microsystems ライカマイクロシステムズ株式会社 | 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 | This product is a diagnostic assistant device for pathological whole slide image used for assisting pathologists in evaluating and diagnosing digital pathological tissue images through automatic capture, display, and... Robotics, IoT, and other devices · Clinical evaluation report | PMDA list · Review report (EN) |
| 2026-02-03 | Improved (clinical data) | Nucleus 8 Sound Processor Nucleus 8 サウンドプロセッサ | Nihon Cochlear Co., Ltd. 株式会社日本コクレア | Auditory electrical stimulator 人工内耳 | Class III | Partial change | 250 | Nucleus 8 Sound Processor and Cochlear Implant 6 (hereinafter referred to as "the products") are Auditory electrical stimulator (Note: Auditory electrical stimulator is the term name) used in patients with bilateral... Ophthalmology and Otorhinolaryngology · Clinical evaluation report | PMDA list · Review report (EN) |
| 2026-02-03 | Improved (clinical data) | コクレアインプラント6 JP | Nihon Cochlear Co., Ltd. 株式会社日本コクレア | Auditory electrical stimulator 人工内耳 | Class III | Partial change | 250 | Nucleus 8 Sound Processor and Cochlear Implant 6 (hereinafter referred to as "the products") are Auditory electrical stimulator (Note: Auditory electrical stimulator is the term name) used in patients with bilateral... Ophthalmology and Otorhinolaryngology · Clinical evaluation report | PMDA list · Review report (EN) |
| 2026-02-03 | Improved (no clinical data) | INHANCE リバース人工肩関節システム JP | Johnson & Johnson K.K. ジョンソン・エンド・ジョンソン株式会社 | total shoulder replacement* 全人工肩関節 | Class III | New approval | — | — | PMDA list |
| 2026-02-03 | Improved (no clinical data) | INHANCE 人工肩関節システム JP | Johnson & Johnson K.K. ジョンソン・エンド・ジョンソン株式会社 | total shoulder replacement* 全人工肩関節 | Class III | New approval | — | — | PMDA list |
| 2026-02-03 | Improved (no clinical data) | SELUTION SLR PTA薬剤溶出バルーンカテーテル JP | MedAlliance LLC | balloon expandable angioplasty catheter* バルーン拡張式血管形成術用カテーテル | Class IV | Partial change | — | — | 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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