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PorTal Access secures FDA clearance for vascular access ports

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PorTal Access secures FDA clearance for vascular access ports
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PorTal Access secures FDA clearance for vascular access ports covers the U.S. Food and Drug Administration clearance of PorTal Access’s implantable vascular access ports for long-term bloodstream access. Miami-based PorTal received the greenlight for its FLEXI-PORT family, designed to provide flexible access via veins in the chest or upper arm, aiming to reduce discomfort tied to rigid titanium or hard plastic ports and to lessen the need for continuous needle pricks for blood draws or IV therapies such as chemotherapy. The device comes in two sizes—5 French (1.67 mm) and 6 French (2 mm)—and is indicated for adult and paediatric use. Company COO Angela Dotson said the clearance is the first “true innovation” in chemo ports in more than three decades. Commercialization in the U.S. will begin with provider and partner engagement plus clinician training.

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