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LAKE OSWEGO, Oregon – BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of the BIOMONITOR IV implantable cardiac monitor (ICM), its latest innovation to improve the standard of care in cardiac monitoring. The device, featuring BIOTRONIK’s advanced, AI-powered* SmartECG algorithm, will make its debut at the Heart Rhythm Society Congress 2023 in New Orleans.
False positive atrial fibrillation detections add to the already heavy workload of clinicians who monitor their ICM patients and can make effective diagnosis difficult. BIOMONITOR IV was engineered with SmartECG, which includes advanced algorithms to reduce 86% of all false positive detections while preserving 98% of true episodes1. This innovative technology delivers more detection accuracy to healthcare professionals, reducing the false positive alerts and helping them achieve timely and accurate diagnosis of certain heart conditions.
In addition to the SmartECG technology, BIOMONITOR IV is the first ICM to discriminate between premature atrial contractions (PACs) and premature ventricular contractions (PVCs). This marks a significant step forward in the field of remote cardiac monitoring by providing healthcare professionals with reliable PAC and PVC trends for risk stratification and diagnosis.
The remote patient monitoring workflow is also set to receive a major boost with the introduction of BIOMONITOR IV. New features such as patient initiated On-Demand Transmissions, Customizable Indication-Based Alert Templates, and Remote Filtering Options are designed to streamline the review process, allowing healthcare professionals to manage patients more effectively by providing what they need, when they need it.
"Our customers have expressed the desire for an innovative device that reduces false positive alerts to provide more efficient care for their patients. With BIOMONITOR IV, we are able to meet the needs of our customers and patients," said David Hayes, MD, Chief Medical Officer at BIOTRONIK Inc. "BIOMONITOR IV represents our commitment to advancing the field of cardiac diagnosis and allowing clinicians to focus on what’s most important – the patient."
The Heart Rhythm Society Congress 2023 provides a platform for healthcare professionals to exchange knowledge and advancements in arrhythmia management. BIOTRONIK looks forward to sharing their latest innovation with the Congress attendees.
References
*AI algorithm is applicable for AF detection only
1 Data on file. With AF filtering criterion set to Very Specific in the Home Monitoring Service Center. Reduction is relative to performance without SmartECG.
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