US-based medical device and digital health company Element Science has received the CE mark certification for Jewel, its novel Patch Wearable Cardioverter Defibrillator (P-WCD).

The company also secured the UK Conformity Assessed (UKCA) marking for Jewel P-WCD, from the Notified Body, the BSI Group.

The Jewel P-WCD is a novel, water-resistant wearable defibrillator designed to detect and treat severe arrhythmias in patients at temporarily elevated risk of sudden cardiac arrest (SCA).

It addresses the limitations associated with traditional garment-based WCDs, where challenges related to patient comfort and compliance resulted in avoidable deaths.

The device continuously monitors a patient’s heart, treats specific life-threatening rhythms, and protects during normal daily activities, including showering, sleeping, and moderate exercise.

It comes with the Jewel Mobile App, which transmits therapy information to the patient’s medical team in near real-time to enable timely patient care, said the digital health company.

Element Science founder, president and CEO Uday Kumar said: “Out-of-hospital SCA remains a significant problem in the United States and Europe with around only about 10% of patients surviving.

“The Jewel was developed to address the compliance issues of garment-based WCDs by focusing on user experience design and by incorporating advanced machine learning algorithms, both of which are approaches common in consumer wearables but relatively uncommon in medical device development.

“Gaining the CE mark under the rigorous European Union Medical Device Regulation (EU MDR) as well as the UKCA mark are testaments to the strength of the development, testing, and clinical results of the Jewel P-WCD.”

The effectiveness of the Jewel defibrillator device was validated in the Jewel EP Lab Study, conducted in Prague, Czech Republic.

In the study, 16 patients experiencing ventricular arrhythmias were successfully converted to a normal heart rhythm after a single therapeutic shock.

The Jewel IDE Study, a multicentre, prospective, single-arm study, enrolled 305 patients for up to 180 days to evaluate the safety and effectiveness of the Jewel P-WCD in patients.

Jewel EP Lab Study lead investigator Petr Neužil said: “This novel approach to medical device design has created an exceptional patient experience and advantages that are likely to expand the use of WCDs to many more patients.”

Element Science said that the Jewel P-WCD has been developed focused on better compliance that has been clinically shown to lead to the delivery of lifesaving therapy when required.

Element Science board of directors long-time member Hank Kucheman said: “Element Science is on the leading edge of leveraging advancements in machine learning, wearable technologies, and miniaturisation to revolutionise the way patients receive care.

“Based on my long experience in medical technology development, the rigour of the approach with which the Jewel P-WCD was designed and tested has been validated by these approvals.”