This report summarizes the key news in the medical device and healthcare industry from May 11 to May 17, 2026. This week saw notable developments from the perspectives of regulatory affairs, quality, and business development, including the restructuring of business portfolios by major medical device companies, investments in growth areas such as next-generation CGMs and IVLs, Class I recalls related to pacemakers, and full-year financial results from domestic medical device manufacturers.
This article goes beyond merely summarizing the news; it also organizes key points that medical device manufacturers should consider when entering the Japanese market, submitting regulatory applications, managing post-market safety, and planning overseas expansion.
This Week's Top News
Stryker Completes Acquisition of Amplitude Vascular Systems
Stryker announced on May 7, 2026, the completion of its acquisition of Amplitude Vascular Systems (AVS). AVS is a medical technology company developing a next-generation Intravascular Lithotripsy (IVL) platform for the treatment of calcified lesions in peripheral artery disease (PAD).
According to Stryker's announcement, AVS's technology uses pressure waves generated by carbon dioxide (CO₂) to address calcified lesions. Stryker states that this acquisition will strengthen its product portfolio in the peripheral vascular segment.
Key Regulatory and Business Development Considerations
IVL is a technology area with anticipated growth in the peripheral vascular treatment sector. This acquisition, which involves acquiring technology, exemplifies how major medical device manufacturers expand their product portfolios not only through in-house development but also by incorporating external technologies.
On the other hand, for novel therapeutic devices, it is crucial to clarify the differences from existing products, clinical evaluation, study design, methods of use, risk management, and post-market safety management. When considering expansion into the Japanese market, key discussion points include the potential for utilizing overseas data, evaluation items required domestically, and comparisons with already approved products.
Dexcom Outlines Development Strategy for Next-Generation CGM "G8"
At its 2026 Investor Day, Dexcom presented its development strategy for "Dexcom G8," its next-generation continuous glucose monitor (CGM). According to reports and investor materials, the G8 is expected to be smaller than the current G7 model and feature self-adaptive accuracy correction technology.
The company anticipates submitting the G8 for FDA clearance in 2027, with market launch projected for late 2027 to early 2028. Furthermore, it has been reported that Dexcom is considering future expansion to include multiple analytes, such as ketones, in addition to blood glucose.
Key Regulatory and Business Development Considerations
For medical devices with digital components like CGMs, sensor performance, algorithms, software updates, user interface, data integration, and safety information management are crucial regulatory points.
Moreover, if the scope of measurement is expanded beyond blood glucose, the product's intended use and the scope of performance evaluation may change. When considering an application in Japan, it will be necessary to clarify the positioning of new measurement items and algorithms, not just the equivalence to existing CGMs.
Medtronic to Close California Facility and Reorganize Cardiovascular Portfolio
Medtronic has reportedly announced its intention to close its Santa Rosa, California facility over approximately two years. The company is also proceeding with a review of its business structure within the cardiovascular sector, with reports indicating a reorganization of its cardiac surgery, aortic, structural heart, coronary, and renal denervation businesses.
Regulatory and Business Development Implications
Reorganizations by major medical device manufacturers are not merely about cost reduction; they also impact research and development, production, quality assurance, regulatory affairs, and post-market surveillance systems. For medical devices, manufacturing sites, design control, QMS conformity, and supply continuity are closely linked to regulatory compliance. Therefore, when facilities are changed or businesses are reorganized, it is essential to assess the impact on regulations in each country.
For products destined for Japan, it may be necessary to clarify manufacturing site information, QMS conformity assessment, change management, and supply responsibility.
Boston Scientific Issues Class I Recall for Certain Pacemakers and CRT-Ps
The FDA has classified Boston Scientific's corrective action for certain pacemakers and CRT-Ps (Cardiac Resynchronization Therapy Pacemakers) as a Class I recall, the most serious type. The affected models include ACCOLADE, ESSENTIO, PROPONENT, and ALTRUA 2 (pacemakers), as well as VISIONIST and VALITUDE (CRT-Ps).
This action is a follow-up to previous recalls and aims to improve battery impedance testing performance and address the impact on battery life through the Brady SMR6 software update and revised labeling.
According to the FDA, Boston Scientific has reported 4 deaths and 2,557 serious injuries related to this issue as of March 18, 2026. This action does not involve removing devices from all patients; instead, it addresses the problem through a software update and revised labeling.
Key Regulatory and Quality Assurance Considerations
For implantable medical devices, the impact of malfunctions can be severe, making post-market surveillance, field actions, information provision to healthcare facilities, and software update procedures critically important.
This case highlights how "post-approval management" in medical devices directly impacts product value and business continuity. Particularly for medical devices that include software, lifecycle management is required from the design stage, encompassing cybersecurity, update management, and risk mitigation measures in the event of a malfunction.
Carl Zeiss Meditec Announces Comprehensive Measures for Revenue Improvement
Carl Zeiss Meditec announced its financial results for the first half of fiscal year 2025/26, with sales revenue decreasing by 5.7% year-on-year to €991 million, and adjusted EBITA reaching €60.5 million. Against a backdrop of geopolitical and regulatory uncertainties, more cautious investment decisions, and the impact on its intraocular lens business, the company has indicated its intention to implement comprehensive measures aimed at improving profitability.
The company aims to achieve an annual profit improvement of over €200 million by fiscal year 2028/29. Reports suggest that these measures could affect up to 1,000 employees.
Key Regulatory and Business Development Points
In the fields of ophthalmology and microsurgery, healthcare cost containment, tender systems, regulatory compliance, and changes in market conditions in various countries significantly impact business performance. For medical device manufacturers, it is essential to consider product development in conjunction with reimbursement, procurement systems, post-market activities, and product portfolio review across different countries.
Full-Year Financial Results of Domestic Medical Device Companies
In the full-year financial results for domestic medical device companies for the fiscal year ending March 2026, some companies continued to grow, driven by overseas markets and healthcare businesses. Meanwhile, other companies saw a decline in profitability due to policy impacts in the Chinese market and changes in product composition.
| Company Name | Revenue | Operating Income | Profit Attributable to Owners of Parent |
|---|---|---|---|
| Terumo | ¥1,131.8 billion (YoY +9.2%) | ¥176.3 billion (YoY +11.8%) | ¥135.9 billion (YoY +16.2%) |
| Fujifilm HD | ¥3,357.0 billion (YoY +5.0%) | ¥350.2 billion (YoY +6.1%) | ¥276.7 billion (YoY +6.0%) |
| Sysmex | ¥500.0 billion | ¥51.8 billion | ¥35.4 billion |
Key Points in Regulatory Affairs and Business Development
This week's news highlights the following trends in the medical device industry:
1. Investment in Growth Areas and Portfolio Restructuring Continue
In areas with high growth potential, such as IVL (Intravascular Lithotripsy), CGM (Continuous Glucose Monitoring), surgical assistance robots, and cardiovascular devices, major companies continue to engage in acquisitions and business restructuring. When introducing new technologies to the Japanese market, it is crucial to not only consider their development status overseas but also to clarify the general nomenclature, class classification, differences from already approved products, clinical evaluation, and insurance reimbursement status within Japan.
2. The Growing Importance of Managing Medical Devices Including Software and Digital Elements
As seen in cases involving CGMs and implantable pacemakers, the importance of software, algorithms, update management, and post-market safety management in medical devices is increasing. It is essential to establish a system that covers not only the approval acquisition phase but also post-market defect responses, package insert revisions, and information provision to healthcare facilities.
3. National Policies, Reimbursement, and Procurement Environments Impact Performance
As evidenced by Sysmex's performance in the Chinese market, Carl Zeiss Meditec's market environment in ophthalmology, and Fujifilm's growth in endoscopes and bio-CDMO, it is clear that the performance of medical device and healthcare companies is influenced not only by product strength but also by national policies, insurance reimbursement, procurement systems, and healthcare cost containment measures in each country.
Summary
This week in the medical device and healthcare industry, a prominent trend was the portfolio restructuring and investment in growth areas by major companies. Stryker's acquisition of an IVL technology company, Dexcom's next-generation CGM concept, and Medtronic's cardiovascular restructuring all represent moves to concentrate management resources on growing markets.
On the other hand, the Class I recall of Boston Scientific pacemakers once again highlighted the importance of post-market safety management, software updates, and prompt information provision to healthcare facilities for medical devices. For medical device manufacturers, the quality and safety management system after approval is a critical factor directly linked to business continuity.
Among domestic companies, Terumo and Fujifilm showed solid performance, driven by overseas markets and their healthcare businesses, while Sysmex was affected by policy changes in the Chinese market. Moving forward, market strategies that consider regulations, insurance reimbursement, healthcare cost containment policies, and supply chain risks in each country will remain crucial.
When entering the medical device market, it is important to clarify early on not only the product's technical features but also its JMDN/generic name, class classification, application category, clinical evaluation, QMS, insurance reimbursement, and post-market safety management.
References
- Stryker, “Stryker completes acquisition of Amplitude Vascular Systems to add next-generation IVL technology to peripheral vascular portfolio,” May 7, 2026.
- Dexcom, “Investor Day 2026 Presentation,” May 2026.
- MedTech Dive / Yahoo Finance, “Medtronic to close California site amid restructuring,” May 2026.
https://finance.yahoo.com/news/medtronic-close-california-amid-restructuring-111014360.html
- U.S. FDA, “Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps,” May 7, 2026.
- Carl Zeiss Meditec, “Half Year Financial Communication 2025/26,” May 12, 2026.
- Terumo, “FY2026 Full Year Financial Results Data File,” May 2026.
https://www.terumo.co.jp/system/files/document/2026-05/Presentation_26Q4_datafile.pdf
- FUJIFILM Holdings, “Full-Year Results for the Fiscal Year Ended March 31, 2026,” May 2026.
https://holdings.fujifilm.com/en/news/list/2127
- Sysmex, “Earnings Forecast,” updated May 2026.
https://www.sysmex.co.jp/ir/finance/forecast.html
- McKesson, “McKesson Reports Fiscal 2026 Fourth Quarter and Full Year Results,” May 2026.
- Intuitive Surgical, “Intuitive Announces First Quarter Earnings,” April 21, 2026.