Rhythio Medical announced today that it received FDA breakthrough device designation for its Injectable Electrode System.
The company’s proprietary offering aims to transform cardiac rhythm management. It hopes to enable painless, imperceptible defibrillation and pacing through a minimally invasive approach.
Houston-based Rhythio designed its Injectable Electrode Gel as an alternative to traditional metal leads or shocking coils. The gel itself is the electrode — a soft, conductive hydrogel delivered through a needle directly to the target tissue. Once injected, the gel forms a stable electrical interface. It integrates seamlessly with existing implantable cardioverter defibrillators (ICDs) and pacemakers.
The Rhythio solution can convert conventional high-voltage shocks into gentle, patient-friendly therapies, the company says.
“This breakthrough device designation highlights the FDA’s recognition of our technology’s potential to redefine how lifesaving cardiac therapies are delivered,” said Allison Post, Rhythio founder and CEO. “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.”
Rhythio says it continues to advance preclinical development of its platform, preparing for first-in-human studies.
“Our team’s interdisciplinary expertise in bioelectronics, materials science, and electrophysiology has made it possible to fundamentally reimagine what defibrillation can feel like,” said Dr. Mehdi Razavi, clinical co-founder of Rhythio Medical and director of Electrophysiology Clinical Research and Innovations at the Texas Heart Institute. “For the first time, we have the potential to deliver life-saving defibrillation and pacing that patients don’t have to fear.
“Our goal is to restore rhythm without pain, and to transform the patient experience from one of fear to one of confidence.”
