US-based health tech company Element Science has received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marketing for its digital wearable defibrillator.
The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) continuously monitors heart rhythm and delivers a therapeutic shock to the heart a life-threatening arrhythmia is detected, specifically ventricular tachycardia, or ventricular fibrillation.
The device can also store data related to heart rhythm and events for later analysis by healthcare professionals, with a smartphone app that can transmit the data to healthcare professionals in near-real time.
The effectiveness of the wearable was validated through two studies.In the Jewel EP Lab study conducted in Prague, Czech Republic, the system successfully restored normal heart rhythm in 16 patients experiencing ventricular arrhythmias with a single therapeutic shock.
In the Jewel IDE study (NCT05201495), which involved 305 patients, significant patient compliance and protected time were observed, leading to numerous successful patient saves without any device-related deaths or serious adverse events. Element Science concluded patient enrolment for the trial in May 2023.
The San Francisco-headquartered company raised $145.6m in a Series C funding round led by Deerfield Healthcare and Qiming Venture Partners USA back in 2020, with the funding going towards the completion of clinical studies and the commercial launch of the Jewel P-WCD.
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By GlobalData
In the announcement accompanying the approvals, CEO of Element Science Uday Kumar said: “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.”
According to a report on GlobalData’s Medical Intelligence Center, the wearable technology market is forecast to grow from $99.5bn in 2022 to $290.6bn in 2030, growing at a compound annual growth rate (CAGR) of 14.3%.
In October 2023, the FDA approved Medtronic’s Aurora EV-ICD MRI SureScan extravascular implantable cardioverter-defibrillator and Epsila EV MRI SureScan defibrillation lead, offering defibrillation, backup (pause-prevention) pacing and anti-tachycardia pacing (ATP) therapies.
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- Source: https://www.medicaldevice-network.com/news/element-receives-ce-and-ukca-for-wearable-defibrillator/
