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....
The new 2 mL pre-filled pen option expands individualized treatment choices for hereditary angioedema (HAE) patients, reinforcing Takeda’s commitment to reducing disease burden and improving quality of life....
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....
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....
Breakthrough Neurodiagnostic Device Aims to Transform Early Detection and Treatment of Neurological Disorders Across Europe...
Nippon Express (Taiwan) Co., Ltd. earns medical device QMS certification for its NEXT3 warehouse in Taoyuan, reinforcing its capabilities in compliant storage, packaging, and labeling of medical devices to meet Taiwan’s stringent quality control standards. ...
The U.S. FDA has approved Merilog (insulin-aspart-szjj), Sanofi’s biosimilar to Novolog, marking a significant step toward expanding access to affordable insulin. The approval strengthens competition in the diabetes treatment market, offering a new rapid-acting insulin option for millions of patients. ...
![[L-R]: Ms. Vivien Tan, XP Business Manager, Siemens Healthineers ASEAN; Prof. Dr. dr. Lina Choridah, Sp.Rad (K), Chairwoman Indonesian Woman Imaging Society; Hendya Perbangkara, Head of Diagnostic Imaging, Siemens Healthineers Indonesia](/uploads/articles/l_r__ms_vivien_tan_xp_business_manager_siemens_healthineers_asean-24188.jpg)
