PorTal Access, Inc. Announces Completion of FDA 510(k) Submission for Flexi-Port™, Marking Major Milestone Toward Commercial Launch

Mid-Summer Launch Anticipated for Next-Generation Oncology Vascular Access Platform

MIAMI, May 18, 2026 /PRNewswire/ -- PorTal Access, Inc., a medical device company pioneering next-generation vascular access solutions for oncology, today announced the successful completion of its U.S. Food and Drug Administration (FDA) 510(k) submission for its flagship device, the Flexi-Port™.

"This milestone represents a significant advancement in our mission to modernize vascular access and support the evolving needs of patients," said Dr. Michael Tal, Founder and CEO of PorTal Access, Inc.

The 510(k) submission represents a critical regulatory milestone toward commercialization and reflects the company's continued momentum as it prepares for an anticipated mid-summer launch. The Flexi-Port™ is designed to support efficient vascular access port placement workflows through its unique design and implantation, which includes the only flexible port and smallest incision of any port currently on the market.

"This is a defining moment for PorTal Access and a testament to the dedication of our clinical, engineering, and leadership teams," said Angela Dotson, COO and Head of Business Development at PorTal Access, Inc. "Completing our FDA 510(k) submission brings us one step closer to delivering a differentiated solution designed to prioritize patient satisfaction, clinician ease-of-use, and clinician workflow. We are excited about the impact Flexi-Port™ will have on the future of vascular access and IR."

Clinical and industry leaders have expressed strong enthusiasm for the Flexi-Port™ system and its potential to advance standards of care in vascular access:

"This novel technology has the potential to positively impact a patient's emotional well-being. Through design considerations related to aesthetics, comfort, and device profile, Flexi-Port™ addresses important psychosocial aspects associated with long-term venous therapy."

— Dr. Anne Covey, Interventional Radiologist.

"The PorTal Flexi-Port™ represents a meaningful advancement in the delivery of systemic chemotherapy for cancer patients. The platform is designed with patient-centered considerations in mind, including device profile, comfort, and procedural simplicity."

— Dr. Mark E. Thompson, DO, Cancer Care of Florida

"PorTal's FDA 510(k) submission represents an important operational and investor milestone. The company is addressing an area of care that has historically seen limited innovation, with the potential to meaningfully improve both patient experience and procedural efficiency, especially in women's health."

— Maria Horowitz, Founding Managing Partner, Kidron Capital Assets LP

The Flexi-Port™ reflects PorTal's commitment to advancing innovation in a category that has experienced limited evolution for decades. By enabling a streamlined, minimally invasive placement process and enhancing patient experience, the company aims to address longstanding clinical challenges while expanding access to high-quality vascular care.

About PorTal Access, Inc.

PorTal Access, Inc. is a medical device startup dedicated to developing innovative vascular access solutions for oncology and other long-term infusion therapies.

The Flexi-Port™ system is currently not available for sale.

Media Contact
Angela Dotson
COO & Head of Business Development
PorTal Access, Inc.
Email: [email protected]

SOURCE PorTal Access, Inc.