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We earned ISO 13485:2003 certification, showcasing our commitment to quality and regulatory excellence. This year also marked the FDA clearance of the EsoSure 510(k) and our relocation to our current headquarters to support our growing operations.

We achieved ISO 13485:2016 certification, reflecting our continued dedication to maintaining the highest standards in quality and compliance.

We secured FDA clearance for the RFS Stylet 510(k), further enhancing our portfolio of innovative, high-quality reprocessed devices.

We expanded into international sales and marketing, bringing our innovative solutions to a global audience. This year also marked the FDA clearance of the .035 IVUS 510(k).

We expanded our warehouse facilities to support growing demand and operational efficiency. Additionally, we achieved FDA clearance for the .014 IVUS 510(k).

We enhanced our operational efficiency and compliance by implementing MasterControl and NetSuite software solutions, streamlining quality management and enterprise resource planning.

We achieved FDA clearance for the Turbo Elite 0.9mm OTW 510(k). This year also saw the expansion of our production facility and fulfillment warehouse, enabling us to meet increasing demand and enhance operational capabilities.

We received FDA clearance for the Eagle Eye IVUS 510(k) and we expanded our infrastructure with the opening of a new administration building to support our growing team and operations.