PorTal Access Secures FDA Clearance for FLEXI-PORT Vascular System
The U.S. Food and Drug Administration has granted clearance to PorTal Access for its FLEXI-PORT family of implantable vascular ports, marking the first significant design shift in chemotherapy port technology in over three decades. The system is engineered to provide flexible implantation options for both pediatric and adult patients.
FLEXI-PORT is designed for long-term vascular access and supports placement in either the chest or the arm. Available in 5Fr and 6Fr configurations, the device aims to streamline clinical workflows by requiring smaller incisions compared to traditional models. Dr. Michael Tal, founder and CEO, described the clearance as a validation of the company's efforts to modernize chemotherapy port placement for both providers and patients.
Following the regulatory approval, the Miami-based company is transitioning toward commercialization and clinician training programs. COO Angela Dotson noted that the development process was heavily supported by the medical community, with over 85% of funding sourced from physicians who actively perform or refer patients for port placement. With the FDA milestone achieved, PorTal Access plans to scale its operations and distribution networks across the United States.
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