Boston Scientific Halts TAVR Sales; J&J’s Monarch Robot Shows Promise

Boston Scientific announced it will end global sales of its Acurate TAVR systems, including Neo2 and Prime, due to tougher clinical and regulatory demands. The devices, sold in Europe, won’t seek FDA approval. The decision follows missed trial targets and unclear U.S. approval pathways. The Acurate line generated $200 million in 2024 sales.

Meanwhile, Johnson & Johnson shared positive results for its Monarch robotic bronchoscopy system, showing it reached peripheral lung nodules in over 98% of cases with safety comparable to traditional methods. The TARGET study, involving 679 patients across the U.S., Canada, and Hong Kong, was published April 26 in Chest Journal. The Monarch system, FDA-cleared in 2018, received a software update in March 2025 to enhance accuracy.

10-06-2025