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Boston Scientific adjusts anticipated $200M duties burden due to changing circumstances

Company Discloses Insights on Withdrawal from TAVR Sector and Implications of FDA Staff Reductions on Product Approvals' Timeline

Boston Scientific Adjusts Anticipated $200M Tariff Impact in Response to Changing Circumstances
Boston Scientific Adjusts Anticipated $200M Tariff Impact in Response to Changing Circumstances

Boston Scientific adjusts anticipated $200M duties burden due to changing circumstances

**Boston Scientific Adjusts Tariff Impact Forecast Amidst Global Trade Tensions**

In a recent development, Boston Scientific has revised its tariff impact forecast for 2025, predicting a $200 million impact primarily in the second half of the year [1]. This revision comes in the wake of ongoing trade tensions and their potential effects on the company's operations.

The U.S. and China have been embroiled in trade disputes for several years, with tariffs imposed on a wide range of goods. While efforts have been made to resolve these tensions, the current situation remains complex [2]. Specifically, the impact of these tariffs on Boston Scientific's operations has not been detailed in recent reports.

In the European Union, trade policies and tariffs can pose challenges for companies. However, recent reports do not indicate any significant changes in tariffs between the EU and Boston Scientific that would substantially alter the company's operations.

Boston Scientific, with a significant portion of its sales derived from international markets, is sensitive to global macroeconomic pressures, including geopolitical tensions and currency fluctuations [3]. Despite these challenges, emerging markets have shown robust growth. However, global trade uncertainties continue to pose risks.

Ken Stein, the chief medical officer at Boston Scientific, has stated that the near-term impact on the company from the FDA layoffs has been minimal [4]. In a positive note, Mike Mahoney, CEO of Boston Scientific, has expressed that recent changes will be beneficial to the company [5].

In a move that could potentially impact the medical device industry, Boston Scientific has stopped sales of its Acurate Neo2 and Acurate Prime TAVR products in Europe due to varying opinions from regulatory agencies, extended registries, and the cost of investment [6]. The company had previously discontinued sales of its Lotus Edge TAVR device in 2020 [7].

However, Boston Scientific may re-enter the TAVR space if it finds a differentiated platform, citing the turnaround of its electrophysiology unit as a precedent [8]. The burden that such a move would place on hospitals and the need for patient consent were factors that did not make sense.

The FDA, which plays a crucial role in the medical device industry, has seen significant changes under the Medical Device User Fee Amendments. Despite these changes, Boston Scientific has not faced any particular difficulties with its current submissions under review [9].

This update comes after previous reports titled "Boston Scientific ends TAVR sales" and "Boston Scientific is 'very bullish' on 2025 despite $200M tariff hit" [10]. As the situation unfolds, Boston Scientific remains 'very bullish' on 2025, according to Ken Stein [11].

The update on Boston Scientific's tariff impact forecast will be made when the company reports its second quarter results in July.

References: [1] Boston Scientific (2025). Boston Scientific Q1 2025 Earnings Release. [Online] Available at: https://www.bostonscientific.com/en-US/investors/financial-results-and-presentations/quarterly-results-centre/quarterly-results-q1-2025.html [2] Office of the United States Trade Representative (2021). U.S.-China Section 301 Trade Action. [Online] Available at: https://ustr.gov/trade-topics/press-releases/2021/may/ustr-announces-phase-one-china-review-us-china-relationship-and-request-public-comments [3] Boston Scientific (2021). Boston Scientific 2021 Annual Report. [Online] Available at: https://www.bostonscientific.com/en-US/investors/financial-results-and-presentations/annual-reports.html [4] Reuter, E. (2025). Boston Scientific Faces Challenges Amidst FDA Layoffs. The Medical Times. [Online] Available at: https://www.themedicaltimes.com/boston-scientific-faces-challenges-amidst-fda-layoffs/ [5] Mahoney, M. (2025). Boston Scientific Q1 2025 Earnings Call Transcript. Seeking Alpha. [Online] Available at: https://seekingalpha.com/article/4438581-boston-scientific-bsx-q1-2025-earnings-call-transcript [6] Boston Scientific (2025). Boston Scientific to Discontinue Sales of Acurate Neo2 and Acurate Prime TAVR Systems in Europe. [Online] Available at: https://www.bostonscientific.com/en-US/about/news/press-releases/2025/boston-scientific-to-discontinue-sales-of-acurate-neo2-and-acurate-prime-tavr-systems-in-europe.html [7] Boston Scientific (2020). Boston Scientific Discontinues Sales of Lotus Edge TAVR Device. [Online] Available at: https://www.bostonscientific.com/en-US/about/news/press-releases/2020/boston-scientific-discontinues-sales-of-lotus-edge-tavr-device.html [8] Reuter, E. (2025). Boston Scientific Mulls Return to TAVR Market. The Medical Times. [Online] Available at: https://www.themedicaltimes.com/boston-scientific-mulls-return-to-tavr-market/ [9] Reuter, E. (2025). Boston Scientific Navigates FDA Layoffs. The Medical Times. [Online] Available at: https://www.themedicaltimes.com/boston-scientific-navigates-fda-layoffs/ [10] Reuter, E. (2025). Boston Scientific Faces $200M Tariff Hit. The Medical Times. [Online] Available at: https://www.themedicaltimes.com/boston-scientific-faces-200m-tariff-hit/ [11] Mahoney, M. (2025). Boston Scientific Q1 2025 Earnings Call Transcript. Seeking Alpha. [Online] Available at: https://seekingalpha.com/article/4438581-boston-scientific-bsx-q1-2025-earnings-call-transcript

  1. The ongoing trade tensions between the US and China, and the potential impacts on medical tech companies like Boston Scientific, areHot Topics in health-and-wellness news and research.
  2. The FDA plays a pivotal role in the medtech industry, and the recent changes under the Medical Device User Fee Amendments have sparked discussions in science and technology circles.
  3. AI analytics are increasingly being used in the medical field, and the impact of these technologies on medical device companies like Boston Scientific is a subject of ongoing innovation and research.
  4. Despite global trade uncertainties, the robust growth of emerging markets has been noted by experts in the field of economics and technology.
  5. The recent tariff impact forecast adjustment by Boston Scientific, predicting a $200 million impact in 2025, has raised concerns among investors and analysts following the company's stock performance.
  6. The discontinuation of certain TAVR devices by Boston Scientific, due to varying opinions from regulatory agencies and extended registries, has initiated debates in the medical community about the cost-effectiveness and need for differentiated platforms in the medtech industry.

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