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# Boston Scientific’s AVVIGO+ Guidance Device Cleared
- URL: https://www.fdaweb.com/boston-scientifics-avvigo-guidance-device-cleared/
- Published: 2023-09-27T12:00:00.000Z
- Updated: 2026-09-14T18:58:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155429

FDA has cleared a Boston Scientific 510(k) for its AVVIGO+ Multi-Modality Guidance System, which the company describes as a streamlined platform that enhances the intravascular imaging and physiology experience. It is intended to integrate best-in-class percutaneous coronary intervention (PCI) guidance tools into one system, “so users across the cath lab can perform faster, more efficient procedures,” the company says. The device features a 15-inch touchscreen tableside control to operate the system in a sterile field, and a flexible option to choose a floor mount vs. boom mount configuration.

Additionally, the company says AVVIGO+ offers “Automated Lesion Assessment” that leverages machine learning to automatically deliver key measurements, diameters, and borders to help healthcare providers perform procedures.