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Boston Scientific readjusts anticipated $200M tariff impact due to evolving situation

Company reveals further insights on its departure from TAVR market and the influence of FDA staff reductions on product evaluation timelines.

Boston Scientific adjusts estimated $200M import duty impact due to evolving circumstances
Boston Scientific adjusts estimated $200M import duty impact due to evolving circumstances

Boston Scientific readjusts anticipated $200M tariff impact due to evolving situation

In a recent development, Boston Scientific Corporation, a leading medical device company, has announced that it will be updating its $200 million tariff impact forecast due to changes in the U.S.-China and U.S.-EU tariff landscape.

The initial forecast, announced last year, anticipated a $200 million tariff impact in 2025, primarily in the second half of the year. However, with the temporary pause in escalating U.S.-China tariffs, similar to adjustments seen by Johnson & Johnson, Boston Scientific plans to update this forecast to reflect recent changes.

CEO Mike Mahoney made this announcement at the Bernstein conference, stating that the world is in a better situation than when the current forecast was made. Despite the tariff challenges, Boston Scientific remains confident it can absorb the tariff costs through higher sales and discretionary spending cuts, supported by expanded U.S. manufacturing capacity.

This adaptive approach aligns with the broader medtech industry trend, where firms are managing tariffs by shifting production and cutting costs. It’s important to note that tariffs between the U.S. and Europe are also in flux, adding further uncertainty to the overall tariff impact.

Meanwhile, Ken Stein, chief medical officer at Boston Scientific, has assured that the review teams at the FDA are largely intact and there haven't been any particular difficulties with Boston Scientific's submissions currently under review. Stein also noted that the long-term impact on Boston Scientific will depend on the effects at some of the offices of innovation within the FDA.

In another development, Boston Scientific has decided to end sales of its transcatheter aortic valve replacement devices, Acurate Neo2 and Acurate Prime TAVR, due to regulatory and investment-related issues in Europe. Full-year sales of these devices in Europe were around $200 million.

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. The updated outlook will be provided when Boston Scientific reports second quarter results in July.

It’s worth noting that Boston Scientific stopped selling its Lotus Edge TAVR device in 2020. The situation with the European Union is in flux but there have been signs of progress in recent days. Stein did not indicate any immediate changes in interactions with the FDA.

This article focuses solely on Boston Scientific's interactions with the FDA and its tariff forecast, without discussing any other companies or devices in relation to these matters. The article also does not provide information about any new submissions Boston Scientific has made to the FDA, nor does it mention any potential impact on Boston Scientific's tariff forecast due to interactions with the FDA.

  1. Amid the changing tariff landscape, Artificial Intelligence (AI) and analytics are expected to play a crucial role in Boston Scientific's update of its $200 million tariff impact forecast.
  2. The medical technology (medtech) industry is taking a proactive approach towards managing tariffs, with companies like Boston Scientific adapting production and cutting costs.
  3. As Boston Scientific moves to end sales of certain devices, innovation in the health-and-wellness sector remains a priority, with the company expressing interest in re-entering the space if it finds a differentiated platform.
  4. While the temporary pause on escalating U.S.-China tariffs offers a momentary reprieve, the ongoing tariff challenges between the U.S. and Europe add further uncertainty to the overall impact.
  5. Science and technology will continue to drive advancements in the medtech industry, with Boston Scientific's ceased sales of its transcatheter aortic valve replacement devices in Europe serving as a case study for the complexities of navigating regulatory and investment landscape.
  6. Despite the current challenges, the FDA remains a critical partner for medtech companies like Boston Scientific, with the agency's review teams maintaining connection with the firm and its ongoing submissions.

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