PMDA · devices & SaMD · monthly list
New and improved medical devices approved in Japan in December 2025, in English.
Last updated: 2026-09-26 · 27 approvals
PMDA lists 27 device approvals in December 2025: 4 new device(s), 8 improved device(s) with clinical data and 15 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-12-24 | Improved (clinical data)SaMD | デジタルバイオマーカー DNP-AS JP | AMI株式会社 JP | phonocardiography software* 汎用心音計用プログラム | Class II | New approval | 456 | Program (SaMD) · Performance study using existing Japanese clinical data | PMDA list |
| 2025-12-24 | Improved (no clinical data) | コスモフィックス サージカルガイド JP | 大阪冶金興業株式会社 JP | patient-specific single-use bone surgery instrument* 患者適合型単回使用骨手術用器械 | Class II | New approval | — | — | PMDA list |
| 2025-12-22 | Improved (clinical data) | PillCam SB 3 Capsule Endoscopy System PillCam SB 3 カプセル内視鏡システム | Covidien Japan Inc. コヴィディエンジャパン株式会社 | Capsule imaging and tracking device カプセル型撮像及び追跡装置 | Class II | Partial change | 187 | The product is a capsule imaging and tracking device to provide images for the diagnosis of small intestinal disease. Gastroenterology, Genitourinary and Reproductive Medicine · Clinical evaluation report | PMDA list · Review report (EN) |
| 2025-12-22 | Improved (no clinical data)SaMD | 内視鏡手術支援プログラム SurVis-Pel JP | 株式会社Jmees JP | 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 |
| 2025-12-22 | Improved (no clinical data) | セプターMini JP | Terumo Corporation テルモ株式会社 | central circulation occlusion therapy endovascular catheter* 中心循環系閉塞術用血管内カテーテル | Class IV | New approval | — | — | PMDA list |
| 2025-12-22 | Improved (no clinical data) | Shockwave C2 Aero コロナリー IVL カテーテル JP | Shockwave Medical Japan株式会社 JP | 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 | — | — | PMDA list |
| 2025-12-22 | Improved (no clinical data)SaMD | 医用画像解析ソフトウェア EIRL Colon Polyp JP | LPIXEL Inc. エルピクセル株式会社 | 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 | Partial change | — | — | PMDA list |
| 2025-12-19 | New device | remede System remedeシステム | Zoll Respicardia, Inc. ZOLL Respicardia, Inc. | Implantable phrenic nerve electrical stimulator 植込み型横隔神経電気刺激装置 | Class IV | New approval | 1793 | An implantable phrenic nerve electrical stimulator designed to induce diaphragm contraction through transvenous phrenic nerve stimulation in adult patients with moderate to severe central sleep apnea who are... Brain/Circulatory, Respiratory, Neurology and Psychiatry · Foreign clinical study | PMDA list |
| 2025-12-19 | Improved (clinical data) | PHIL System† PHILシステム | Terumo Corporation テルモ株式会社 | Central circulatory intravascular embolization prosthesis 中心循環系血管内塞栓促進用補綴材 | Class IV | New approval | 267 | Brain/Circulatory, Respiratory, Neurology and Psychiatry · Japanese clinical study | PMDA list |
| 2025-12-19 | Improved (clinical data) | PillCam COLON 2 Capsule Endoscopy System PillCam COLON 2 カプセル内視鏡システム | Covidien Japan Inc. コヴィディエンジャパン株式 | Capsule imaging and tracking device カプセル型撮像及び追跡装置 | Class II | Partial change | 242 | The product is a capsule imaging and tracking device to provide images for the diagnosis of colorectal disease. Gastroenterology, Genitourinary and Reproductive Medicine · Clinical evaluation report | PMDA list · Review report (EN) |
| 2025-12-19 | Improved (clinical data) | プレシジョン7 JP | Alcon Japan Ltd. 日本アルコン株式会社 | reusable tinted vision correction contact lens* 再使用可能な視力補正用色付コンタクトレンズ | Class III | New approval | 266 | Ophthalmology and Otorhinolaryngology · Foreign clinical study | PMDA list |
| 2025-12-19 | Improved (no clinical data) | AXIUM デタッチャブル コイルシステム JP | Medtronic Japan Co., Ltd. 日本メドトロニック株式会社 | Central circulatory intravascular embolization prosthesis 中心循環系血管内塞栓促進用補綴材 | Class IV | Partial change | — | — | PMDA list |
| 2025-12-19 | Improved (no clinical data) | テーパーロックセメンテッドフェモラルステム JP | ジンマー・バイオメット合同会社 JP | Hip prosthesis femoral component 人工股関節大腿骨コンポーネント | Class III | New approval | — | — | PMDA list |
| 2025-12-15 | New device | Rezum System Rezum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 | Water vapour delivery system for prostatic tissue 前立腺組織用水蒸気デリバリーシステム | Class III | Partial change | 76 | A water vapour delivery system for prostatic tissue used to reduce prostatic tissue involved in prostatic hyperplasia and relieve symptoms and obstruction. The application was submitted mainly to add a generator with... Gastroenterology, Genitourinary and Reproductive Medicine · No clinical study | PMDA list |
| 2025-12-15 | New device | FARASTAR Console FARASTAR コンソール | 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 | 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 | 109 | A pulse generator for pulsed field ablation procedures used for the treatment of arrhythmia. The application was submitted to add a console type and an interconnection box for accessories. (A “partial change”... Cardiopulmonary Circulation · No clinical study | PMDA list |
| 2025-12-15 | Improved (no clinical data) | ExcelsiusGPS ロボティックナビゲーションシステム JP | グローバスメディカル株式会社 JP | robotic surgical navigation system* 手術用ロボットナビゲーションユニット | Class III | New approval | — | — | PMDA list |
| 2025-12-09 | New device | Embosphere エンボスフィア | Merit Medical Japan K.K. メリットメディカル・ジャパン株式会社 | Central circulatory intravascular embolization prosthesis 中心循環系血管内塞栓促進用補綴材 | Class IV | Partial change | 361 | A central circulatory intravascular embolization prosthesis used for arterial embolization in patients with hypervascular tumors or arteriovenous malformation. The application was submitted to add the indication for... Brain/Circulatory, Respiratory, Neurology and Psychiatry | PMDA list |
| 2025-12-09 | Improved (no clinical data)SaMD | 手術映像認識プログラム キノスラ JP | Direava株式会社 JP | 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 |
| 2025-12-09 | Improved (no clinical data) | ViewFlex X ICE Catheter SE† ViewFlex X ICEカテーテルSE | Abbott Medical Japan LLC アボットメディカルジャパン合同会社 | central circulation intravascular ultrasound catheter* 中心循環系血管内超音波カテーテル | Class IV | New approval | — | — | PMDA list |
| 2025-12-09 | Improved (no clinical data) | EnSite X EP System† EnSite X EP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 | cardiac catheter testing device* 心臓カテーテル用検査装置 | Class III | Partial change | — | — | PMDA list |
| 2025-12-09 | Improved (no clinical data) | Nanoスーチャーテープ JP | Arthrex Japan合同会社 JP | non-absorbable artificial ligament* 非吸収性人工靱帯 | — | New approval | — | — | PMDA list |
| 2025-12-09 | Improved (no clinical data)SaMD | 肺がんコンパクトパネルDxマルチコンパニオン診断システム JP | 株式会社DNAチップ研究所 JP | 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 |
| 2025-12-05 | Improved (clinical data) | SeQuent Please Ph ドラッグ イルーティング バルーンカテーテル JP | Nipro Corporation ニプロ株式会社 | balloon expandable angioplasty catheter* バルーン拡張式血管形成術用カテーテル | Class IV | New approval | 995 | Brain/Circulatory, Respiratory, Neurology and Psychiatry · Japanese clinical study | PMDA list |
| 2025-12-03 | Improved (clinical data) | SweatWatch(スウェットウォッチ) JP | 株式会社グレースイメージング JP | sweat lactate monitoring system* 汗乳酸モニタリングシステム | Class II | New approval | 636 | Cardiopulmonary Circulation · Japanese clinical study | PMDA list |
| 2025-12-03 | Improved (clinical data) | TightRail family TightRail ファミリー | Philips Japan Corporation 株式会社フィリップス・ジャパン | Pacemaker/defibrillator lead removal kit ペースメーカ・除細動器リード抜去キット | Class IV | New approval | 230 | The product is a pacemaker/defibrillator lead removal kit for easy removal of cardiac leads. Cardiopulmonary Circulation · Clinical evaluation report | PMDA list · Review report (EN) |
| 2025-12-03 | Improved (no clinical data)SaMD | 肺結節CT画像検出支援ソフトウェア Careverse LungDoc JP | 株式会社CESデカルト 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 |
| 2025-12-03 | Improved (no clinical data) | ArTT オーギュメント JP | エノヴィスジャパン株式会社 JP | artificial bone implant* 人工骨インプラント | 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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