SeeMedX has announced the submission of our 510(k) premarket notification to the U.S. Food and Drug Administration for our non-invasive cardiac monitoring device. Learn more about what this means for our company.
SeeMedX Files 510(k) with FDA for Innovative Cardiac Monitoring System to Transform Heart Failure Care
This device is designed to allow medical professionals to have real-time insights into cardiac performance and fluid status. SeeMedX’s technology enables clinicians to make informed decisions, optimizing heart failure treatment with greater speed and safety than current options.
“I am really excited about the potential difference this could make to the management of patients with heart failure, whether it’s in preventing hospitalization or simply making the diagnosis of heart failure.” – Dr. Peter Ganz
“This submission marks a major milestone for SeeMedX in advancing heart failure care,” said Deborah Simpson, CEO of SeeMedX. “After the unexpected loss of my father, I made it my personal mission to develop a life-changing solution for heart failure treatment. Our goal is to empower clinicians with tools that ultimately improve outcomes for patients everywhere.”
Healthcare professionals often face limited choices dominated by invasive, high-risk, and costly options.
Why SeeMedX is Transformative for Heart Failure Treatment
SeeMedX’s non-invasive cardiac device provides precise hemodynamic measurements including Zo (fluid status) and CO (cardiac output), allowing clinicians to detect volume overload and other heart failure symptoms earlier than traditional methods.
Key Highlights of the SeeMedX Cardiac Monitoring Device:
- Real-time insights: Delivers actionable data on Zo (fluid status) and CO (cardiac output), enabling clinicians to make more timely decisions to optimize heart failure treatment.
- Painless experience: Non-invasive, enhancing patient comfort and clinical efficiency.
- Streamlined hospital workflows: Facilitates quicker interventions, enhancing hospital efficiency and supporting timely clinical decisions.
Expert Endorsement:
Dr. Peter Ganz, Professor of Medicine and a distinguished leader in Cardiology at the University of California, San Francisco (UCSF), shared his endorsement:
“I am really excited about the potential difference this could make to the management of patients with heart failure, whether it’s in preventing hospitalization or simply making the diagnosis of heart failure.” He then added, “It would be a huge benefit to patients, it also might be a huge benefit to the country financially.”
With over 6 million Americans affected by heart failure, costing the healthcare system more than $30 billion annually, SeeMedX’s device addresses a critical need. Watch our impact video to see how SeeMedX’s non-invasive monitor is poised to transform heart failure care.
Pending FDA clearance, SeeMedX is preparing for a U.S. commercial launch, with plans to pursue regulatory approvals in other global markets.
About SeeMedX
SeeMedX’s mission is to improve lives through non-invasive monitoring, empowering healthcare professionals with fast, painless, and intuitive real-time data. Our advanced technology sets a new standard for monitoring cardiac performance and fluid status, enabling clinicians to make informed, timely decisions for optimizing heart failure treatment and improving outcomes. To learn more, visit www.seemedx.com.
About Dr. Peter Ganz
Dr. Peter Ganz is the Director of the Center of Excellence in Vascular Research at Zuckerberg San Francisco General Hospital and a Professor of Medicine at UCSF. A pioneer in cardiovascular research, he earned his M.D. from Harvard, trained at Mass General, and led cardiovascular research at Brigham and Women’s for 25 years before joining UCSF in 2008. Today, Dr. Peter Ganz supports SeeMedX’s mission to advance non-invasive cardiac monitoring, bringing his expertise and visionary approach to improving heart failure management.