Health Data Works, a healthcare technology company, announced that its Access Tracker™ software platform has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation highlights the potential of Access Tracker™ to significantly improve vascular access management for patients undergoing dialysis.
Addressing a Critical Need in Dialysis Care
The management of failed or failing dialysis access grafts and fistulas presents a substantial economic burden, with market estimates ranging from $3 billion to $5 billion annually in the US alone. Access Tracker™ is designed to address this challenge by providing a comprehensive platform for managing vascular access across dialysis centers, vascular clinics, and hospitals.
How Access Tracker™ Works
Designed for use by interventional radiologists, vascular surgeons, nephrologists, and dialysis technicians, the software allows for the recording and analysis of cannulation sites and identification of potential hazards such as stents, pseudoaneurysms, and stenoses. These features aim to reduce access risks, mitigate complications, and improve patient outcomes. Ongoing data gathered through the platform will be used to develop advanced AI tools to further enhance capabilities moving forward, such as recommending optimal zones for future cannulation.
Enhancing Communication and Interoperability
Access Tracker™ also addresses a major problem in the dialysis care ecosystem: the lack of communication and interoperability between healthcare settings. By enabling real-time data sharing and visualization, the platform ensures seamless collaboration, giving all stakeholders access to the information they need to provide the best possible care.
Expert Perspectives
Shannon Beardsley, MD, CEO and cofounder of Health Data Works, stated, "This milestone underscores our commitment to improving dialysis care through innovative technology. Access Tracker™ is designed to support clinicians in delivering safer, more effective patient care. We are honored to receive the FDA’s recognition of its potential impact." Dr. Erin Moore, an endovascular surgeon and key advisor to Health Data Works, added, "Access Tracker™ addresses critical gaps in vascular access management. By combining insights from real-time data and clinical expertise, this technology has the potential to mitigate complications like aneurysm formation and access scarring while extending the life of vascular access for dialysis patients."
About the Breakthrough Device Designation
The FDA’s Breakthrough Device Designation is awarded to certain medical devices that offer significant potential benefits over existing technologies for the treatment or diagnosis of serious or life-threatening conditions and allows for expedited development and review pathways. This designation does not change regulatory requirements but emphasizes the device’s capacity to bring significant benefits to patients and healthcare systems alike.
