Company: ISRG
Filing Date: 2025-04-23
Form Type: 10-Q
Source: 0001035267-25-000109
Chunk: 75

Company: INTUITIVE SURGICAL INC
Filing Date: 2025-04-23
Form: 10-Q
Item: Item 2
Chunk 75
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. Many suspicious lesions found in the lung may be small and difficult to access, which can make diagnosis challenging, and Ion helps physicians obtain tissue samples from deep within the lung, which could help enable earlier diagnosis. Our Ion endoluminal system has received FDA clearance, and OUS regulatory clearances include European certification in accordance with the EU MDR, regulatory clearance in South Korea, and National Medical Products Administration (“NMPA”) regulatory clearance in China. We plan to seek additional clearances, approvals, and certifications for our Ion endoluminal system in OUS markets over time.

The success of new product introductions depends on a number of factors including, but not limited to, pricing, competition, geographic market and consumer acceptance, the effective forecasting and management of product demand, inventory levels, the management of manufacturing and supply costs, and the risk that new products may have quality or other defects in the early stages of introduction.

Tariff Update

On February 1, 2025, the U.S. imposed 25% tariffs on imports from Mexico and Canada, with several subsequent changes related to exemptions and effective dates, including an exemption for any goods that are within the scope of the United States-Mexico-Canada Agreement (“USMCA”). We currently manufacture a significant majority of our instruments and accessories in Mexicali, Mexico, most of which are certified under the requirements of USMCA and, therefore, have not been subject to the recently imposed tariffs. As a result, the impact of tariffs on us was not material in the first quarter of 2025.

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On April 2, 2025, the U.S. imposed a 10% universal tariff on all imports that are not subject to the USMCA. The U.S. announced additional tariffs that vary by country, which are currently paused for 90 days. We import some raw materials and finished goods from outside of the U.S., which are subject to these tariffs, including our endoscopes, a majority of which are manufactured in Germany. We anticipate that some of our suppliers will incur incremental tariffs and may pass on those additional costs to us.

On April 7, 2025, the U.S. imposed a tariff on all imports from China, currently up to 145%. Our operations involve importing certain raw materials and finished goods from China, which are subject to the U.S. tariff. Concurrently, China has imposed a 125% tariff on all imports from the U.S. We import sub-assemblies to support our local da