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Home » Biotronik earns FDA approval for Acticor Sky, Rivacor Sky defibrillators

Biotronik earns FDA approval for Acticor Sky, Rivacor Sky defibrillators

April 23, 2026 By Sean Whooley

Biotronik Rivacor Sky and Acticor Sky defibrillators
The Rivacor Sky and Acticor Sky defibrillators [Image courtesy of Biotronik]
Biotronik announced today that it received FDA approval for its Acticor Sky and Rivacor implantable defibrillator systems.

Approval of the implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems extends the Germany-based company’s cardiac rhythm portfolio with novel technologies designed to support physiology-driven therapies and improve day-to-day clinical workflows.

Biotronik said the new Sky family of devices introduces solutions to address a broad range of clinical challenges. Those include left bundle branch area pacing (LBBAP). The system features a new anti-tachycardia pacing (ATP) suite to expand atrial and ventricular ATP options as well. It continues to offer Biotronik’s DX single-lead technology for atrial sensing without an additional atrial lead.

According to the company, its new defibrillators aim to deliver. clearer insights and more efficient workflows. Its new HeartInsight feature provides automatic, multi-parameter insight into worsening heart failure through a single actionable alert. Meanwhile, its MRI Guard 24/7 streamlines MRI access by eliminating the need for pre- and post-scan programming appointments.

The devices build on previously approved Acticor and Rivacor versions. Biotronik continues to advance its cardiac rhythm portfolio elsewhere as well, including with two-lead defibrillation technology.

“Acticor Sky and Rivacor Sky bring together what care teams have been asking for: therapy options that closely follow cardiac physiology and features that support daily workflows,” said Dr. David Hayes, chief medical officer, Biotronik. “We are excited to bring these technologies to more of our physician customers and their patients.”

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Implants, Regulatory/Compliance, Structural Heart Tagged With: Biotronik

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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