Rhythio wins FDA breakthrough nod for injectable electrode tech for defibrillation

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.

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