A new medical device initiated at The Texas Heart Institute at Baylor College of Medicine, has received FDA Breakthrough Device Designation. The Injectable Electrode System, a first-of-its-kind technology from Rhythio Medical, was designed to deliver painless, imperceptible defibrillation and cardiac pacing.

At the forefront of this innovation is Mehdi Razavi, MD, PhD, Director of Electrophysiology Clinical Research and Innovations at the Texas Heart Institute at Baylor College of Medicine and Clinical Co-Founder of Rhythio Medical. Dr. Razavi emphasizes the transformative potential of the technology: “For the first time, we have the ability to deliver life-saving defibrillation and pacing that patients don’t have to fear. Traditional shocks can be painful and traumatic, sometimes causing patients to delay or disable therapy. Rhythio’s system is designed to remove that barrier, creating a new standard of care that is both effective and humane.”

Rhythio’s Injectable Electrode Gel is a soft, conductive hydrogel that acts as the electrode itself, delivered through a needle directly to target tissue. Once in place, it forms a stable electrical interface compatible with existing implantable cardioverter defibrillators (ICDs) and pacemakers, converting conventional high-voltage shocks into gentle, patient-friendly therapy. This approach represents a radical shift from traditional metal leads and shocking coils, transforming how cardiac rhythm management can be delivered.

The FDA Breakthrough Device designation recognizes technologies with the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. It provides Rhythio with prioritized regulatory engagement and review, expediting clinical and development milestones.

Dr. Razavi, along with former colleague and Founder and CEO at Rhythio Medical, Allison Post, PhD, is advancing preclinical development and preparing for first-in-human studies, aiming to redefine patient experiences in cardiac care.  Post explains in the recent announcement from Rhythio Medical, “For decades, defibrillation has been synonymous with pain. Rhythio’s injectable system is designed to make these therapies imperceptible—transforming the patient experience and expanding access to treatment.”

This milestone underscores the combined expertise of Rhythio’s leadership, including Dr. Elizabeth Cosgriff-Hernandez, Co-Founder, whose work in biomaterials underpins the hydrogel electrode’s safety, durability, and precision. Together, the team is forging a new paradigm in bioelectronic therapies that seamlessly integrates advanced materials with life-saving cardiac rhythm management.