Redsense is actively assessing potential impacts on its operations following the newly announced worldwide tariffs by President Donald Trump. While the tariffs introduce new uncertainties, the company remains in close dialogue with its customs brokers, U.S. distribution partners, and customers to monitor developments and coordinate responses. Although it is unclear if and how Medtech tariffs will affect medical devices, we are monitoring the situation carefully; including the focused efforts or numerous U.S. and EU-UK Medtech groups that are actively engaged in conversations with the White House.

"Our partners know we are all in this together, and all are committed to finding solutions that support everyone involved. With 3-6 months of product already in place at our US distribution partners, we don't anticipate any disruption to customer demand or product availability in the short term" says Sebastien Bollue, CEO of Redsense Medical AB.

Separately, the anticipated launch of the Redsense Clamp-originally targeted for the end of Q1 2025-is currently still pending. The summative evaluation of the product's usability study was submitted in February 2025, and the documentation remains under review. Feedback from the test house is still awaited.

The delay is primarily due to the high workload many test facilities and notified bodies have faced in the wake of MDR implementation, which has resulted in longer processing times across the industry. Redsense remains fully engaged with the test facility and their review process and is prepared to move forward promptly once approval is granted.