Key Developments

On February 8, 2024, ZOLL, an Asahi Kasei company that manufactures medical devices and software solutions, announced that the ZOLL AED 3 defibrillator has been certified under the European Union's (EU) Medical Device Regulation 2017/745, referred as EU MDR.
On January 25, 2024, Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, announced that its Notified Body, the BSI Group, has certified its novel Patch Wearable Cardioverter Defibrillator (P-WCD) with the European Union's CE mark and the Great Britain’s UK Conformity Assessed (UKCA) mark.
In October 2023, Medtronic plc, a global leader in healthcare technology, announced that the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation leads have been approved by the U.S. Food and Drug Administration (U.S. FDA) to treat dangerously fast heart rhythms that can cause sudden cardiac arrest (SCA).
In January 2023, Mindray, an innovative medical device manufacturer, announced the launch of BeneHeart D60 and D30 defibrillators, the next generation in the BeneHeart line. The new BeneHeart defibrillators aim to increase resuscitation standards by offering improved dependability, professional comprehensive diagnosis and monitoring tools, and a whole-process quality improvement solution for both in-hospital and pre-hospital rescue.