US-based medical device company Element Science has secured the US Food and Drug Administration (FDA) approval for its Jewel Patch Wearable Cardioverter Defibrillator (Patch-WCD).
The advanced, water-resistant device is designed to detect and treat life-threatening arrhythmias in patients with a temporary elevated risk of sudden cardiac arrest (SCA).
The Jewel Patch-WCD continuously monitors a patient’s heart, providing treatment for specific life-threatening rhythms.
It provides continuous protection during daily activities, including showering, sleeping, and moderate exercise.
The Jewel Mobile App enhances patient care by transmitting therapy information to the medical team in near real-time.
The device integrates human-centred design principles with advanced machine learning, offering a paradigm shift in wearable cardiac defibrillation.
Its water-resistant feature and discreet profile enable patients to maintain their lifestyle without the limitations of traditional devices.
Element Science founder, president, and CEO Uday Kumar said: “The Jewel Patch-WCD is the culmination of a vision to give patients a life-saving device that seamlessly integrates into their daily lives.
“FDA approval represents more than a regulatory milestone; it’s a leap forward in how we, as clinicians, think about using cutting-edge therapeutic technology to empower patients to live their fullest lives, even when at risk of sudden cardiac arrest.
“I have been a long-time believer in the idea that individuals using wearable innovations should feel like people, and not patients, and so we are proud to lead the transformation of care through devices like the Jewel Patch-WCD.”
The Jewel Patch-WCD is equipped with a sophisticated algorithm and a user-friendly design.
It serves as a reliable guardian for patients and offers protection against sudden cardiac arrest at home and during daily activities.
The Jewel Patch-WCD has also received the European Union’s (EU) CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking in January 2024.
The FDA approval highlights its clinical safety and effectiveness, reinforcing Element Science’s leadership in wearable life-saving cardiovascular technology.
Cedars-Sinai Smidt Heart Institute cardiology chair Christine Albert said: “The Jewel marks a significant advancement in safeguarding high-risk patients from sudden cardiac arrest. Its cutting-edge design and technology address a critical gap in cardiac care.”
Element Science commercial head Lee Smith Jr. said: “Bringing the Jewel Patch-WCD to market represents a transformative moment for patients at risk of sudden cardiac arrest.
“The Jewel Patch-WCD represents a new freedom for these patients, enabling them to live with confidence while staying protected by life-saving technology.
“This is the type of innovation that doesn’t just advance healthcare; it changes lives, and we’re excited to bring that impact to patients and their families.”
