The company says Biomonitor III documents suspected arrhythmias or unexplained syncope in patients who have experienced cardiac arrhythmias or who are at risk for cardiac arrhythmias.
Biotronik SE & Co. KG says its new injectable cardiac monitor offers superior signal clarity and battery life to competing systems, which allows physicians to monitor patients for arrhythmias in less time per case and at lower cost.
Biomonitor III, which earned a 510(k) from the US Food and Drug Administration in July, automatically records arrhythmias, including atrial...
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
