Falcon/Xpress (Falcon/Xpress)

The Falcon/Xpress is a noninvasive peripheral vascular diagnostic system that measures systolic blood pressures, pulse volume recording (PVR) waveforms, blood flow velocities, and photoplethysmography (PPG) signals at various limb sites. It is intended for use by trained medical personnel in hospitals, clinics, and physicians' offices to evaluate peripheral vascular pathology and is not intended for fetal applications or use in sterile fields.

The Falcon/Xpress is similar to the predicate Falcon device in using pneumatic technology, continuous-wave Doppler, and PPG sensors. Key differences include fewer pressure channels (2 default, expandable to 8 versus 10 for Pro or 4 for Quad/ABI+), 2 PPG sensors (versus 4-5), 2 Doppler ports (4, 8 MHz only, versus 3 ports or 4, 8, 10 MHz), no temperature sensor, external battery capability, and compact design (27x20x5.5 cm versus 34x31x9.5 cm).

IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-37 (ultrasonic medical equipment), ISO 80369-1 (small-bore connectors), ISO 10993-1 (biocompatibility), FDA Track 1 (acoustic output), and February 2023 FDA Guidance for diagnostic ultrasound systems.

The Falcon/Xpress uses identical underlying pneumatic, Doppler, and PPG measurement technologies and performs the same clinical measurements (segmental pressures, ABI, PVR, blood flow velocity) as the predicate, supporting identical specialty test protocols. Reductions in channel/sensor counts do not affect measurement performance because each channel and sensor operates independently; fewer channels merely require operator workflow adjustments similar to lower-tier predicate models (Quad/ABI+) already on the market. The addition of external battery and optional tablet mounting does not alter the intended use or measurement capability.