Medical Device Industry News Weekly | Latest Trends in TAVR, Neurostimulation, and Surgical Assist Robots (May 18-24, 2026)

In the medical device industry from May 18-24, 2026, investments, acquisitions, and product updates were prominent in growth areas such as chronic pain treatment, TAVR, surgical robots, aortic arch treatment, and liquid biopsy.

This article summarizes the movements of major overseas companies, financial results of domestic medical device and healthcare companies, and regulatory considerations for introducing products into the Japanese market.

This Week's Highlights
Major News from Overseas Medical Device Manufacturers
Financial Performance Trends of Domestic Medical Device and Healthcare Companies
Regulatory Affairs and Japanese Market Entry Perspectives
Summary
Sources and References
MK Consulting Support

1. This Week's Highlights

Medtronic announced its intention to acquire SPR Therapeutics, a developer of peripheral nerve stimulation (PNS) devices for chronic pain, for approximately $650 million.
Boston Scientific invested $1.5 billion in TAVR developer MiRus, acquiring an option to purchase the company's heart valve business.
Intuitive Surgical is preparing over 100 updates for its da Vinci 5 surgical robot.
Artivion completed the acquisition of Endospan, a developer of the NEXUS Aortic Arch System for aortic arch treatment.
Guardant Health received FDA approval for its expanded Guardant360 Liquid CDx.
Domestically, attention is on Nihon Kohden and Konica Minolta's financial results for the fiscal year ending March 2026.

2. Major News from Overseas Medical Device Manufacturers

Medtronic to Acquire SPR Therapeutics for Approximately $650 Million

Medtronic has announced its intention to acquire SPR Therapeutics, a company specializing in peripheral nerve stimulation (PNS) technology for chronic pain treatment, for approximately $650 million in cash.

SPR Therapeutics' "SPRINT PNS System" is a device that provides temporary PNS therapy. For Medtronic, this acquisition will expand its neuromodulation portfolio. In the chronic pain sector, options for drug therapy, implantable stimulation devices, and minimally invasive treatments are growing, and interest in non-opioid therapies is also increasing.

Boston Scientific Invests $1.5 Billion in TAVR Developer MiRus

Boston Scientific has invested $1.5 billion in MiRus, a company developing a balloon-expandable TAVR system, acquiring a 34% stake in the company. Furthermore, Boston Scientific has secured an option to acquire additional heart valve businesses under certain conditions.

While Boston Scientific has faced challenges in the TAVR business in the past, this investment signifies a renewed focus on the structural heart disease market, which is a growing segment. TAVR remains a highly competitive field, driven by an aging population and the demand for minimally invasive treatments.

Intuitive Surgical Prepares Feature Updates for da Vinci 5

Intuitive Surgical is reportedly preparing over 100 updates and user experience improvements for its surgical robot, the "da Vinci 5."

These updates include features to support communication with remote physicians, enhanced training and simulation capabilities, and expanded utilization of force feedback-related functions. In the surgical robot market, where competitors such as Johnson & Johnson, Medtronic, and CMR Surgical are present, continuous improvement of existing platforms has become crucial.

Artivion Completes Acquisition of Endospan

Artivion has completed the acquisition of Endospan, developer of the "NEXUS Aortic Arch System" for aortic arch disease. NEXUS is a branched stent graft system for aortic arch repair, which received FDA PMA (Pre-Market Approval) in April 2026.

The aortic arch is anatomically complex, and traditional surgical repair in this area has historically been highly invasive. Endovascular treatment devices like NEXUS are gaining attention as a minimally invasive treatment option for high-risk patients.

Guardant Health Receives FDA Approval for Guardant360 Liquid CDx

Guardant Health has received FDA approval for a new version of its blood-based cancer genomic profiling test, "Guardant360 Liquid CDx." According to the company, the new test evaluates a broader genomic region than its predecessor and retains all existing companion diagnostic indications.

Liquid biopsies are increasingly being utilized for patients for whom tumor tissue collection is difficult, or when rapid identification of genetic mutations is needed to guide treatment decisions. However, upon introduction to Japan, key considerations will include its classification as an in vitro diagnostic (IVD) or medical device program, its positioning as a companion diagnostic, and the organization of insurance reimbursement.

3. Financial Performance Trends of Domestic Medical Device and Healthcare Companies

Summary of Financial Results for the Fiscal Year Ending March 2026

Company Name	Net Sales	Operating Income	Net Income Attributable to Owners of the Parent
Nihon Kohden Corporation (6849)	235,099 million yen (up 4.3% YoY)	18,745 million yen (down 9.5% YoY)	14,513 million yen (up 2.9% YoY)
Konica Minolta (4902)	1,087,738 million yen (down 3.6% YoY)	49,869 million yen	30,268 million yen (returned to profitability)

Nihon Kohden Corporation

Nihon Kohden Corporation reported net sales of 235,099 million JPY, operating income of 18,745 million JPY, and net income attributable to owners of the parent of 14,513 million JPY for the fiscal year ended March 2026. By product category, patient monitoring equipment increased by 14.4% year-on-year, and therapeutic equipment increased by 5.8%. In contrast, biological information monitors decreased by 0.8%.

For the fiscal year ending March 2027, the company forecasts net sales of 232.5 billion JPY and operating income of 23.5 billion JPY. The key focus will be on how they manage increasing costs and improve profitability by region, while maintaining a trend of increasing revenue.

Konica Minolta

Konica Minolta reported sales of 1,087,738 million JPY, operating income of 49,869 million JPY, and profit attributable to owners of the parent of 30,268 million JPY for the fiscal year ending March 2026. Although sales decreased compared to the previous fiscal year, the company successfully turned a loss into a profit through structural reforms and the selection and concentration of businesses.

While not exclusively a medical device company, Konica Minolta has a healthcare segment that includes diagnostic imaging. The progress of its business portfolio review and profitability improvement will continue to be closely watched.

Sonova

Hearing aid giant Sonova achieved 5.9% sales growth in local currencies for the 2025/26 fiscal year. For the 2026/27 fiscal year, the company anticipates sales growth of 5-8% and Core EBIT growth of 7-10% in local currencies.

In the field of hearing-related devices, there is ongoing enhancement of AI, connectivity, and software functionalities. This is intensifying competition, not only in traditional hardware sales but also in digital features.

4. Regulatory Affairs and Japanese Market Entry Perspective

This week's news featured many acquisitions, FDA approvals, and product updates, primarily from the US and Europe. However, even for medical devices that have obtained FDA approval or CE Mark overseas, their positioning under Japan's Pharmaceutical and Medical Device Act (PMD Act) must be individually confirmed before they can be sold in Japan.

For products such as TAVR, surgical assistance robots, liquid biopsies, and neurostimulation devices, the following points are particularly important:

Medical device class classification in Japan, and the distinction between approval, certification, and notification
Clarification of equivalence or differences compared to already approved products
Whether overseas clinical data can be utilized for Japanese applications
Setting the intended use, indications, and target patient population
Necessity of clinical evaluation reports, clinical trials, registry data, etc.
Evaluation policy when including software, cybersecurity, and AI functions
Positioning for insurance reimbursement
Necessity of PMDA consultations

5. Summary

In the medical device industry from May 18 to May 24, 2026, there was a flurry of activity in growth areas, including Medtronic's acquisition of SPR Therapeutics, Boston Scientific's investment in MiRus, Intuitive Surgical's da Vinci 5 update, Artivion's acquisition of Endospan, and Guardant Health's Guardant360 Liquid CDx approval.

From a market perspective, fields such as chronic pain, TAVR, surgical robots, aortic treatment, and liquid biopsy are seeing advancements in minimally invasive procedures, personalized medicine, and sophisticated software functionalities.

However, when introducing these products to the Japanese market, it is crucial to comprehensively consider not only the presence of overseas approval but also the classification under Japan's Pharmaceutical and Medical Device Act (PMD Act), differences from already approved products, clinical evaluation, PMDA consultations, and insurance reimbursement. For medical devices with a proven track record overseas, it is particularly important to reconfigure documentation for Japanese applications and tailor explanations to address domestic review points.

6. Sources and References

This article was created by referencing the following publicly available and press materials.

Support from MK Consulting

MK Consulting Co., Ltd. provides regulatory consulting services for medical devices, covering Pharmaceutical and Medical Device Act (PMDA Act) compliance, PMDA approval, third-party certification, clinical evaluation, and insurance reimbursement listing.

Specifically, we support the design of regulatory strategies tailored to product characteristics and clinical practice, particularly in the fields of gastrointestinal endoscope accessories, biliary and pancreatic devices, biliary and pancreatic stents, and catheters.

For overseas manufacturers entering the Japanese market, we can provide practical support, from restructuring overseas approval documents, clinical data, and technical documents for Japanese applications, to PMDA consultations, approval/certification applications, and coordination with Designated Marketing Authorization Holder (DMAH) candidate companies.