Domestic News
MedBank Obtains Class II Medical Device Manufacturing and Sales License
【Company/Organization】 MedBank Inc.
【Category】 Regulatory Trends and Business Strategy
MedBank, a company developing image diagnostic support solutions utilizing AI technology, obtained a “Class II Medical Device Manufacturing and Sales License” on April 15, 2026. This allows the company to establish an integrated system covering design, development, manufacturing, pharmaceutical affairs application, and sales for medical devices ranging from general medical devices to controlled medical devices. The company aims for early manufacturing and sales approval for its currently developing “Ultrasound Image Diagnosis AI Support Software.”
Against the backdrop of the government’s “17 Strategic Fields” priority investment policy, domestic medical AI startups are accelerating their efforts to establish in-house systems for pharmaceutical affairs application and sales. The ability to rapidly introduce products to the market without relying on external outsourcing is expected to contribute to the popularization and strengthened competitiveness of domestic medical AI solutions.
PHC Launches Digital Pathology Solution “E1000Dx” in Japan
【Company/Organization】 PHC Corporation
【Category】 New Products and Technological Innovation
PHC has obtained medical device manufacturing and sales approval in Japan for its next-generation digital pathology solution “E1000Dx,” which supports pathological diagnosis, and has commenced sales. By combining a high-definition scanner with AI analysis, it aims to improve the diagnostic accuracy of pathologists and reduce their workload.
Amidst the severe shortage of pathologists, digitalization and AI-assisted diagnosis are urgent issues. The introduction of a highly reliable system, approved by Japan’s PMDA (Pharmaceuticals and Medical Devices Agency), marks a significant step forward in the digital transformation (DX) of pathological diagnosis in medical institutions nationwide.
International News
Medtronic Completes Acquisition of CathWorks for $585 Million
【Company/Organization】 Medtronic / CathWorks
【Category】 M&A / Business Strategy
Medtronic has completed the acquisition of CathWorks, a company that develops FFRangio, a non-invasive fractional flow reserve (FFR) technology that aids in the diagnosis of coronary artery disease. The acquisition is valued at up to $585 million. Medtronic has been investing in CathWorks and co-promoting its technology since 2022, and has now formally acquired it as a wholly-owned subsidiary.
The technology, which can assess blood flow conditions from angiography images without the need for invasive wires, directly leads to reduced patient burden and shorter procedure times. By fully integrating this technology into its cardiovascular portfolio, Medtronic is expected to further enhance its competitive advantage in the global interventional treatment market.
GE HealthCare and RadNet (DeepHealth) Expand AI Mammography Collaboration
【Company/Organization】 GE HealthCare / RadNet (DeepHealth)
【Category】 Technological Innovation / AI
GE HealthCare announced an expanded strategic collaboration with DeepHealth, a subsidiary of RadNet, to enhance the provision of AI-powered mammography tools. DeepHealth's cloud-based “Breast Suite” will be integrated into GE's “Senographe Pristina” system, offering AI-driven automated lesion detection (CAD) and automated breast density assessment capabilities.
In breast cancer screening, AI-powered diagnostic support is already in practical use. This deep collaboration between a major modality manufacturer and an AI specialist company is expected to enable healthcare institutions worldwide to establish more accurate and consistent screening systems without disrupting existing workflows.
Siemens Healthineers Clarifies Schedule for Full Spin-off by February 2027
【Company/Organization】 Siemens AG / Siemens Healthineers
【Category】 Management & Business Strategy
Siemens AG, a German company, has announced its plan to put to a vote at its Annual General Meeting in February 2027 the full spin-off of its healthcare division, Siemens Healthineers, through a direct allocation of shares to shareholders.
Although Siemens Healthineers is already listed, its complete independence from the parent company will enable more agile management decisions and flexible capital market financing. The independence of a global leader in diagnostic imaging and in-vitro diagnostics has the potential to further accelerate future large-scale M&A activities and technology investments.
Conavi Medical Obtains FDA Approval for Next-Generation Hybrid Intravascular Imaging System
【Company/Organization】 Conavi Medical
【Category】 Regulatory Trends & New Products
Conavi Medical, a Canadian company, has received U.S. FDA (Food and Drug Administration) approval for its next-generation hybrid imaging system that can simultaneously perform intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The company aims for a limited market launch starting in late 2026.
This is a groundbreaking technology that allows for simultaneous evaluation of IVUS (superior in penetration depth) and OCT (superior in high resolution), which previously required separate catheters, in a single pullback. It is attracting attention as a “practice-changing” technology that supports decision-making in complex coronary interventions and dramatically improves the efficiency of catheter lab workflow.
Featured Topic: AI Implementation in Gastrointestinal Endoscopy
Currently, in the field of gastrointestinal endoscopy AI, technology is evolving from lesion "detection" to "quantification" (size and classification). Beyond merely identifying abnormalities, the implementation of AI technology that quantifies lesion size and invasiveness is progressing. This advancement reduces variability due to physician subjectivity and enables the accumulation of more objective diagnostic data.
References
- MedBank Co., Ltd.: Acquired "Class II Medical Device Manufacturing and Sales Business" License
- Yakuji Nippo: Domestic Approval and Release of PHC's Digital Pathology Solution "E1000Dx"
- MedTech Dive: Medtronic closes $585M purchase of CathWorks
- MassDevice: GE HealthCare expands collaboration with RadNet's DeepHealth
- Reuters: Siemens plans shareholder vote on Siemens Healthineers spin-off
- Cardiovascular Business: FDA clears next-gen hybrid system for intravascular imaging
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