New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation...
With CE Mark approval, CathVision’s AI-powered ECGenius System is set to launch in the European market, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....
Building on FDA clearance, IceCure files for Israeli approval of its XSense™ System, expanding minimally invasive cryoablation solutions across multiple medical specialties in line with the growing trend of surgical de-escalation. ...
Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance....
Cambridge-based medical device startup SurgiBox Inc. receives utility and design patents for its SurgiField™ technology, enhancing mobile surgical capabilities with advanced airflow and smart control innovations....
With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible, multi-night testing and seamless remote monitoring. With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring a...
With advanced SBOM management, automated vulnerability tracking, and FDA-ready reports, Helm reduces risk, lowers costs, and accelerates regulatory approval for medical device manufacturers....
With CE Mark certification, the AI-powered ECGenius System is now approved for commercialization in the European Economic Area, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....
Engineered for precision, durability, and space efficiency, the patented FlexyCord™ coiled cable delivers unmatched reliability in critical medical environments. ...
Breakthrough Neurodiagnostic Device Aims to Transform Early Detection and Treatment of Neurological Disorders Across Europe...
