Biotronik announced today that it received FDA approval for its Selectra 3D catheter and Solia S lead for use in left bundle branch area pacing (LBBAP). The FDA’s approval of the new labeling for the pacing combination makes the products the first and only stylet-driven lead and dedicated delivery catheter system approved by the FDA […]
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The latest AI-powered cardiology devices you need to know
Artificial intelligence is increasingly becoming integral in advancing medtech, including devices to treat heart disease. Think AI-powered cardiology. AI-driven technologies could improve diagnostic capabilities, patient outcomes and clinical workflows. These technologies leverage machine learning algorithms and vast datasets to provide more accurate diagnoses and patient care. In cardiology, AI-powered devices are changing how heart conditions […]
Biotronik kicks off resorbable magnesium scaffold trial
Biotronik today announced the enrollment of the first patient in its BIOMAG-II trial evaluating the Freesolve resorbable magnesium scaffold (RMS). The BIOMAG-II trial compares the next-generation Freesolve scaffold to a contemporary drug-eluting stent (DES). Lake Oswego, Oregon-based Biotronik developed the scaffold for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe […]
Biotronik unveils new AI-powered insertable cardiac monitor
Biotronik announced that it received CE mark approval and completed the first European implant of its latest insertable cardiac monitor (ICM). The BioMonitor IV features AI capabilities for false positive reduction. The AI cuts false positives for AFib, bradycardia, tachycardia and pause. According to Biotronik, its SmartECG reduces 86% of false detections across all major […]
Biotronik wins breakthrough nod for Freesolve BTK resorbable magnesium scaffold
Biotronik this week announced it received FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS). The Berlin, Germany-based cardiac rhythm company designed Freesolve for individuals suffering from chronic limb-threatening ischemia (CLTI). The newly launched device is not coronary artery lesions. “This breakthrough device designation for the Freesolve RMS for BTK treatment […]
Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold
Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold. The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions. Lake Oswego, Oregon-based Biotronik based its system on the […]
Biotronik, IMDS launch new coronary microcatheter
Biotronik announced that it launched the Micro Rx catheter for enhancing guidewire support during percutaneous coronary interventions (PCI). Interventional Medical Device Solutions (IMDS) manufactures Micro Rx and Biotronik has exclusive distribution rights. Micro Rx marks the fourth IMDS product brought to the U.S. by Biotronik, joining the NHancer Rx, TrapIT and ReCross catheters. The Micro […]
Biotronik announces 100,000th implant of ICDs with AFib monitoring
Biotronik announced today that it hit 100,000 implanted single-lead implantable cardioverter defibrillators (ICDs) with DX Technology. DX Technology enables direct atrial sensing for AFib detection and monitoring. Since its introduction in 2009, clinicians in more than 80 countries around the world have used DX ICDs. The technology offers reliable, timely information about atrial arrhythmias and […]
Biotronik has positive data for its spinal cord stimulation tech
Biotronik today announced positive results from a clinical trial for its Neuro Prospera spinal cord stimulation (SCS) system. The BENEFIT-02 trial evaluates the Resonance multiphase stimulating paradigm used in the Neuro Prospera system. It looked at the safety and effectiveness of the stimulator in treating patients with chronic pain. Contrary to other currently available SCS […]
Biotronik announces first U.S. implant of next-gen pacemaker
Biotronik today announced the first U.S. implantation of its new, next-generation Amvia Edge pacemaker system. The FDA approved the Biotronik portfolio of Amvia Edge pacemakers last month. Dr. Raul Weiss completed the procedure at Mount Sinai Medical Center in Miami, Florida. “I was very pleased to have been a part of the first implant of […]
FDA approves next-gen family of pacemakers from Biotronik
Biotronik announced today that the FDA approved its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P). Lake Oswego, Oregon-based Biotronik designed Amvia Edge as the market’s smallest single-chamber MR conditional pacemaker. It offers a set of patient-centric solutions coupled with automated workflow efficiency. The pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology. […]
