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Investing.com -- Shares of Boston Scientific (NYSE:BSX) tumbled 4% following the company’s announcement that it is halting global sales of its ACURATE neo2 and ACURATE Prime Aortic Valve Systems. The decision comes after discussions with regulators led to increased clinical and regulatory requirements to maintain and obtain approvals across various markets.
On May 28, 2025, Boston Scientific revealed that the heightened demands from regulators would necessitate additional resources and investments that the company considers prohibitive. Consequently, the medical device manufacturer is also abandoning efforts to secure U.S. FDA approval for the ACURATE systems, as well as approvals in other regions.
Despite the setback, Boston Scientific has stated its expectation to meet its previously issued guidance for the second quarter and full year of 2025 regarding reported and organic sales and adjusted earnings per share. This guidance was initially provided on April 23, 2025. However, the company has not reaffirmed its second quarter and full year 2025 GAAP EPS guidance at this time and plans to share more details during its second quarter 2025 earnings call.