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Column & Insights

Practical information and industry updates on Japan's medical device regulatory affairs and PMDA submissions.

Industry NewsApril 20, 2026

Medical Device Industry Latest News Report (Updated April 21, 2026)

Latest trends in the medical device industry as of April 21, 2026. This report summarizes key domestic and international topics, including MedBank obtaining Class II Medical Device Manufacturing and Sales Business許可, PHC launching digital pathology “E1000Dx” in Japan, Medtronic completing the acquisition of CathWorks for $585 million, GE HealthCare and DeepHealth expanding their AI mammography collaboration, Siemens Healthineers clarifying its full spin-off schedule, and Conavi Medical's hybrid IVUS/OCT system receiving FDA approval.

Industry NewsApril 19, 2026

Medical Device Industry Latest News Report (Updated April 20, 2026)

Latest trends in the medical device industry as of April 20, 2026. This report summarizes key domestic and international topics, including GE Healthcare Japan's domestic debut of photon-counting CT at ITEM2026, the imminent opening of Medtec Japan 2026 (April 21-23), Abbott's Q1 earnings driven by medical device sector growth, Israel's MeMed receiving FDA Breakthrough Device designation for its infection differentiation device, and the forefront of AI implementation in gastrointestinal endoscopy.

Industry NewsApril 18, 2026

Medical Device Industry Latest News Report (April 19, 2026 Edition)

This report summarizes the latest trends in the medical device industry as of April 19, 2026. Key domestic and international topics include the upcoming Medtec Japan 2026 (April 21-23, Tokyo Big Sight), medical device certification for the AR medical imaging program "TH-ZEY (ZEUS)," Johnson & Johnson's MedTech division reporting strong financial results with a 7.7% year-on-year increase, and CMS proposing the abolition of the additional payment system for breakthrough devices.

Industry NewsApril 17, 2026

Medical Device Industry Latest News Report (Updated April 18, 2026)

Latest trends in the medical device industry as of April 18, 2026. This report summarizes key domestic and international topics, including PMDA's introduction of generative AI "Microsoft Copilot" across all operations, Terumo's Fenestrated TREO abdominal aortic stent graft receiving FDA Breakthrough Device designation, ITEM2026 (International Technical Exhibition of Medical Imaging) currently being held, advancements in "virtual chromoendoscopy" AI technology in the gastrointestinal endoscopy field, and the UK government's allocation of £1.5 million to support FemTech medical devices.

Industry NewsApril 16, 2026

Medical Device Industry Latest News Report (Updated April 17, 2026)

Latest trends in the medical device industry as of April 17, 2026. This report summarizes key domestic and international topics, including Korean company Neurophet's Japan debut of its Alzheimer's AI "AQUA AD" at ITEM2026, Nidek's announcement of a simultaneous binocular vision testing device, Philips' FDA approval of its AI-powered spectral CT "Verida," FDA approval of Rapid Medical's TIGERTRIEVER 25, positive interim trial results for AVITA Medical's Cohealyx, and the UK government's allocation of £1.5 million to support FemTech.

Industry NewsApril 15, 2026

Medical Device Industry Latest News Report (Updated April 16, 2026)

The latest trends in the medical device industry for the third week of April 2026. This report summarizes key domestic and international topics, including PMDA's introduction of generative AI "Microsoft Copilot" for all executives and employees, the approaching Medtec Japan 2026, FDA approval for Cala Health's kIQ Plus, approval for Phantom Neuro's first human clinical trial, Medtronic's IN.PACT AV 12-month real-world data, and Boston Scientific's $88.4 million investment in its Irish R&D facility.

Industry NewsApril 14, 2026

Medical Device Industry Latest News Report (Updated April 15, 2026)

The latest trends in the medical device industry for the third week of April 2026. This report summarizes important domestic and international topics, including Fujifilm's new version of the CT system "SCENARIA View Plus," the holding of ITEM2026, IMDRF's proposed AI lifecycle management framework, Avanos Medical's $1.3 billion acquisition by PE, J&J MedTech's strong financial results, and trends in overseas FDA approvals and funding.

Industry NewsApril 13, 2026

Medical Device Industry Latest News Report (Updated April 14, 2026)

Summary of the latest trends in the medical device industry for the second week of April 2026. Key domestic and international topics include Canon Medical's launch of Japan's first photon-counting CT "Ultimion," Fujifilm's cloud-based PACS "SYNAPSE LEAD Cloud," Sysmex's Alzheimer's disease blood biomarker reagent, Stryker's acquisition of AVS, NVIDIA's announcement of surgical assistance AI "GR00T-H," Artivion's NEXUS Aortic Arch System FDA approval, and the polarization of digital health funding.

Industry NewsApril 11, 2026

Medical Device Industry Latest News Summary (April 12, 2026)

Latest trends in the medical device industry as of April 12, 2026. This summary includes important domestic and international topics such as Philips' launch of the AI-powered multi-energy spectral CT "Verida," the announcement of the helium-free MRI "BlueSeal," Asahi Intecc's exclusive distribution agreement for embolic agents, the FDA and MDUFA VI agreement in principle, FDA approval of Stereotaxis' "Synchrony," and Johnson & Johnson's "TECNIS Eyhance" surpassing 10 million eyes.

Industry NewsApril 10, 2026

Medical Device Industry Latest News Summary (April 11, 2026)

This report summarizes the latest developments in the medical device industry as of April 11, 2026. It covers key domestic and international topics, including Toho University's medical device approval based solely on a domestic registry (a first in Japan), the start of pricing discussions at the Central Social Insurance Medical Council for the insurance coverage of iPS cell products, Riverfield's adoption into NVIDIA Inception, FDA Breakthrough Device Designation, and intensifying competition in the surgical assistance robot market.

Industry NewsApril 9, 2026

Medical Device Industry Latest News Summary (April 10, 2026)

A summary of the latest developments in the medical device industry as of April 10, 2026. This includes key domestic and international topics such as Canon Medical's launch of Japan's first photon-counting CT, Nichiban's breathable visualization wearable, Terumo's expansion of its Costa Rica facility, the FDA's maintenance of AI medical device regulations, and the MDUFA VI agreement.

Industry NewsApril 8, 2026

Medical Device Industry Latest News Summary (April 9, 2026)

A summary of the latest developments in the medical device industry as of April 9, 2026, including discussions on health insurance coverage for iPS cell products, Menicon's approval of bone regeneration material, and J&J's European expansion of next-generation PFA devices, among other significant domestic and international topics.

Industry NewsApril 7, 2026

Medical Device Industry Latest News Report (April 8, 2026)

<p>We've compiled the key medical device industry news from April 2026, covering everything from new product approvals and M&A to supply chain challenges and AI/robotics technology.</p>

RegulatoryMarch 24, 2026

[Medical Device Regulatory Approval] 3 Steps to Creating a "Clinical Evaluation Report" to Avoid Clinical Trials and Key Points for PMDA Consultation

For market entry of medical devices in Japan, clinical trials, which require significant cost and time, are the biggest hurdle. However, if conditions are met, it is possible to obtain manufacturing and marketing approval without conducting new clinical trials by utilizing a "Clinical Evaluation Report." This article explains the three main categories for approval without clinical trials, a three-stage process for creating a successful report, and effective ways to utilize PMDA consultation. We introduce a practical approach for efficient and rapid regulatory approval of medical devices.

RegulatoryMarch 8, 2026

Medical Device Approval Process: Overview and Practical Guide

Is the Japanese medical device approval process complex? This article thoroughly explains the four classification categories under the PMD Act and the differences in optimal approval routes based on the presence or absence of certification standards. It covers essential knowledge for successful entry into the Japanese market, including registration required for foreign manufacturers and the establishment of a Marketing Authorization Holder (MAH).

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