Boston Scientific Halts Sales of Heart Device in EU & Foregoes Approval in Other Markets Due to Regulatory Hurdles
Boston Scientific has decided to discontinue sales of its Acurate Prime and Acurate neo2 heart devices in the European Union, a move that will also see the company forgo seeking approval in the U.S. and other international markets. The decision, announced on Wednesday, stems from escalating clinical and regulatory hurdles that the company has deemed too resource-intensive to meet, first reported by Reuters.