A Milestone Moment: FDA Clears Falcon/Xpress for U.S. Launch
Viasonix, a global leader in vascular diagnostic solutions, is thrilled to announce the FDA clearance for our newest peripheral vascular diagnosis machine, the Falcon/Xpress.
This 510(k) clearance, received at the end of 2024 in record time, represents another significant milestone for Viasonix and a perfect way to start the new year.
This achievement follows the recent reception of the CE MDR certificate for the Falcon/Xpress, which has opened doors to European and international vascular diagnostic markets. With these dual regulatory approvals, the Falcon/Xpress is now in an excellent position to make a dramatic impact on clinical vascular diagnostic environments worldwide.
What Makes the Falcon/Xpress So Exciting?
The Falcon/Xpress is designed to reach new vascular diagnostic markets, filling a critical gap in the industry. The vascular physiological diagnosis market already includes several high-end systems, with Viasonix’s Falcon/Pro and Falcon/Quad recognized as among the best in their class.
In contrast, there are low-cost vascular diagnosis systems that often lack advanced functionality and comprehensive clinical diagnostic capabilities. This has left the mid-range cost vascular market without significant device offerings.
The Falcon/Xpress changes this dynamic. It combines the advanced functionality and clinical performance of our existing Falcon systems with an affordable price, effectively meeting the needs of both mid-range and low-cost market segments.
A Message from Viasonix’s CEO
Dr. Dan Manor, President and CEO of Viasonix, shared his excitement about this groundbreaking launch:
“We are incredibly proud to meet the growing demand for an affordable yet high-quality vascular diagnostic device. With the Falcon/Xpress, we offer American customers a range of solutions, from cost-effective devices to the most sophisticated systems.
This reinforces our commitment to delivering the best commercial vascular machines to meet the diverse needs of the clinical community. With the CE certificate and now FDA clearance, we are ready to make a significant impact in both American and international markets. Early orders suggest that 2025 will be a fantastic year for the Falcon/Xpress.”
Clinical Applications of the Falcon/Xpress
The Falcon/Xpress stands out with its comprehensive range of diagnostic capabilities that cater to diverse clinical needs:
- Doppler Measurements: Precise and reliable measurements for vascular assessments.
- Ankle-Brachial Index (ABI): Critical for detecting peripheral arterial disease.
- Toe-Brachial Index (TBI): Ideal for patients with non-compressible vessels.
- Pulse Volume Recording (PVR): Comprehensive vascular waveform analysis.
- Segmental Blood Pressures: Detailed diagnostics for localized vascular conditions.
- Venous Reflux Testing: Efficient identification of venous insufficiency.
- Pulse Wave Velocity (PWV): Enables detailed arterial stiffness assessment.
- Exercise Stress Testing: Provides insights into vascular performance under physical stress.
- Raynaud’s Testing: Specialized for evaluating microvascular function and diagnosing Raynaud’s phenomenon.
- And Much More: Fully customizable to include advanced features for specific clinical requirements.
How Does the Falcon/Xpress Meet Diverse Market Needs?
The Falcon/Xpress stands out with its adaptability to various clinical and budgetary requirements.
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Multiple Configurations: The device is available in desktop options, mobile and hand-carried designs, and transportable configurations, making it suitable for diverse medical settings.
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Customizable Software: Users can choose from simple, user-friendly operations to advanced configuration options, similar to those in the existing Falcon systems. The system also supports sophisticated networking capabilities, allowing seamless integration into any clinical workflow.
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Expandability with Cuff Selector: The Falcon/Xpress can extend up to 8 pressure cuffs, providing enhanced diagnostic capabilities for segmental pressure measurements and beyond.
Optional Rechargeable Battery Pack: Enabling seamless movement between patients without requiring a restart.
This versatility ensures that the Falcon/Xpress can answer to the unique needs of any healthcare provider, from small clinics to large hospitals.
A Bright Future
The FDA clearance of the Falcon/Xpress is a major step forward for Viasonix and the global vascular diagnostics market. This innovative solution not only bridges the gap between affordability and advanced performance but also sets new standards for clinical care worldwide.
For more information or to schedule a demo, please leave us a message.
