Medical Device Industry Weekly News (April 27 - May 2, 2026) | PMDA, FDA, M&A Trends

This report provides key trends in the medical device industry for this week (April 27 - May 2, 2026). From the perspective of a regulatory consultant specializing in the gastrointestinal endoscopy field, we will discuss notable topics that significantly impact the industry, such as financial results of major manufacturers, M&A activities, cybersecurity challenges, and the latest regulatory developments.

---

1. Company Trends and Performance: Intuitive Surgical's Strong Earnings and Stryker's Cyberattack Impact

News Highlights

Intuitive Surgical, known for its "da Vinci" surgical robot, announced its Q1 2026 financial results, reporting sales of $2.77 billion, a 23% increase year-over-year, exceeding market expectations [1]. The number of da Vinci systems installed reached 431, with global growth driven by an increase in surgical procedures.

Meanwhile, orthopedic device giant Stryker's Q1 sales were $6.02 billion (up 2.6% year-over-year), significantly below analysts' expectations of $6.35 billion, due to a cyberattack on March 11, 2026 [2]. The attack was carried out by the Iranian hacker group "Handala," which used a wiper attack exploiting the Microsoft Intune environment to erase device data, causing the order processing, manufacturing, and shipping systems to be shut down for approximately three weeks. EPS fell to $2.60 (expected $2.98), and the company stated that the attack had a "meaningful impact" on its performance. Manufacturing facilities were fully restored by the week of April 1.

Furthermore, on April 24, 2026, Medtronic, the world's largest medical device company, also announced unauthorized access to its corporate IT systems [3]. The hacker group "ShinyHunters" claimed to have leaked over 9 million records, including PII (Personally Identifiable Information), which Medtronic is currently verifying. Fortunately, there has been no impact on products, manufacturing, distribution, or patient care, but this incident highlights the growing cybersecurity risks in the medical device industry.

Impact on the Industry

Intuitive Surgical's performance indicates robust global demand for minimally invasive surgery. In contrast, the cases of Stryker and Medtronic demonstrate the risk that vulnerabilities in medical device manufacturers' supply chains and IT infrastructure can directly affect corporate performance and the supply system in healthcare settings.

Of particular note is the revision of Japan's Pharmaceutical and Medical Device Act (PMDA) Basic Requirements in April 2023, which explicitly added cybersecurity requirements in Article 12, Paragraph 3. For foreign manufacturers entering the Japanese market, the establishment of a Software Bill of Materials (SBOM), development of vulnerability response plans, and establishment of post-market security management systems will be prerequisites for approval. The industry as a whole will urgently need to increase security investments and strengthen resilience.

---

2. M&A and Business Strategy: Strategic Acquisitions by J&J and CareDx

News Highlights

Johnson & Johnson (J&J) announced the acquisition of Atraverse Medical, Inc. (a privately held U.S. medical device startup) to expand its cardiovascular portfolio [4]. Atraverse has developed the HOTWIRE Transseptal Access System, an FDA-approved radiofrequency guidewire used for treating conditions such as atrial fibrillation, which has been used in approximately 3,000 cases to date. The system received FDA 510(k) approval in May 2024 and additional approval in December 2025 for an integrated RF generator. One of Atraverse's founders is Steven Mickelsen, who was also a founder of Farapulse, which Boston Scientific acquired in 2021. The transaction is expected to close in Q2 2026, and the financial terms were not disclosed.

Additionally, CareDx, a company specializing in diagnostics for transplant medicine, entered into an agreement to acquire Naveris, a developer of minimal residual disease (MRD) surveillance tests for virus-associated cancers, for up to $260 million (an upfront payment of $160 million + up to $100 million in milestones) to make a full-scale entry into the oncology field [5]. Naveris's flagship product, "NavDx," is a liquid biopsy test for HPV-related cancers, which received Medicare coverage in 2023. Naveris's sales were approximately $34 million in 2025 and $12 million in Q1 2026. The transaction is expected to close in Q3 2026.

Impact on the Industry

J&J's acquisition is part of its strategy to expand its market share in the rapidly growing arrhythmia (ablation) treatment market and will be integrated with its existing platforms, "Varipulse" and "Carto 3 mapping system." Meanwhile, CareDx's acquisition of Naveris demonstrates a diversification of business from its traditional transplant area into the larger market of "cancer genomic diagnostics" (addressable market of $4.5 billion). The trend of large companies acquiring innovative startups with strengths in specific disease areas is expected to continue.

---

3. New Products and Technological Innovation: TaeWoong Medical's SPAXUS Stent Receives FDA Approval

News Highlights

South Korean medical device manufacturer TaeWoong Medical USA announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lumen-Apposing Metal Stent (LAMS) "Niti-S SPAXUS", which supports endoscopic ultrasound (EUS)-guided drainage procedures [6]. The FDA determined that the product was "substantially equivalent" to existing commercially available products (such as Boston Scientific's "Axios").

SPAXUS is a fully covered, self-expanding metal stent featuring a bi-flange structure at both ends and a silicone coating designed to prevent leakage and facilitate removal. Its FDA indications are for:

• Symptomatic pancreatic pseudocysts (≥6 cm in diameter)
• Walled-off necrosis (≥6 cm in diameter)

for transgastric or transduodenal endoscopic drainage.

Impact on the Industry

SPAXUS is a device that enables a minimally invasive approach using gastrointestinal endoscopy for the treatment of pancreatic pseudocysts and walled-off pancreatic necrosis. As an alternative to traditional surgical procedures, it has shown a clinical success rate of 97.1% in a major clinical trial for pancreatic pseudocysts, with no reported device-related serious adverse events.

This approval is expected to further advance the adoption of advanced therapeutic endoscopic solutions in the U.S. market. The LAMS market is currently dominated by Boston Scientific (Axios), but TaeWoong's entry will intensify competition and expand choices for healthcare institutions. For its introduction into the Japanese market, the strategic design of PMDA approval (equivalent to Class III) and insurance coverage (C1 new function category) will be key.

---

4. Regulatory Trends: Insurance Coverage for Software as a Medical Device (SaMD) and European AI Regulations

News Highlights

In Japan, discussions are active regarding the social implementation of Software as a Medical Device (SaMD). In addition to accelerating the review process for regulatory applications by the Pharmaceuticals and Medical Devices Agency (PMDA), strategic considerations for appropriate pricing and insurance coverage of SaMD in the 2026 (Reiwa 8) medical fee revision are ongoing [7].

Meanwhile, as the transition period for the Medical Device Regulation (MDR/IVDR) in Europe approaches its climax, the world's first comprehensive AI law, the "EU AI Act" (effective August 2024, with key provisions applicable from August 2, 2026), is bringing a new turning point for regulatory requirements for AI-powered medical devices [8]. Many AI-powered medical devices will be classified as "high-risk AI systems," requiring additional conformity assessments, including risk management, data governance, technical documentation, human oversight, and cybersecurity measures.

Impact on the Industry

For software-only medical devices, obtaining "regulatory approval" and "insurance coverage" are two sides of the same coin. The modernization of PMDA reviews and the improvement of the insurance system will boost the growth of the domestic digital health market.

On the other hand, for companies aiming for global expansion, compliance with strict European AI regulations will be a new hurdle. In areas where the EU MDR, EU AI Act, and PMDA Basic Requirements for cybersecurity intersect, a strategy incorporating regulatory requirements from each country is essential from the early stages of product development. In particular, manufacturers dealing with AI endoscopes (which are also being implemented in the gastrointestinal endoscopy field) are at a point where they need to seriously consider a regulatory harmonization strategy.