A German medical technology company has become the first to receive regulatory approval for artificial intelligence to function as an independent second reader in breast cancer screening and diagnostic mammography across Europe.
Konan Medical USA has secured CE marking under the European Medical Device Regulation for its objectiveFIELD Analyzer (OFA), enabling distribution across the European Union. The device represents the first FDA 510(k)-cleared objective perimeter that assesses visual field abnormalities through pupillary response measurement rather than subjective patient input
Cambridge-based digital medicine company electronRx has announced the launch of pDx, a medical-grade application designed to enable remote monitoring of chronic respiratory diseases through smartphone, laptop, or tablet devices. The technology will debut at HLTH 2025 in Las Vegas (19–22 October), offering clinicians new capabilities for assessing cardiopulmonary function without requiring in-person consultations.
GE HealthCare has secured FDA 510(k) clearance for its Revolution Vibe CT system, a cardiac imaging platform designed to capture full-heart clarity in a single beat without requiring electrocardiogram trace. The system addresses growing demand for coronary CT angiography (CCTA) as cardiovascular disease continues to account for projected annual deaths exceeding 23 million globally by […]
Dublin-based medical device company Neuromod Devices has secured critical regulatory approvals that will expand global access to its Lenire tinnitus treatment system. The company announced simultaneous approvals for Medical Device Single Audit Program (MDSAP) certification and EU Medical Device Regulation (MDR) compliance.
Siemens Healthineers has unveiled a photon-counting CT scanner specifically designed for radiation therapy planning, aiming to improve treatment accuracy for cancer patients through enhanced imaging capabilities.
Neusoft Medical Systems has announced that its NeuViz P10 photon-counting CT (PCCT) has received market approval from China’s National Medical Products Administration (NMPA). The system represents the first photon-counting CT approved in China and the world’s first wide-body system equipped with an 8-cm detector.
GE HealthCare has announced the launch of its most advanced cardiovascular ultrasound system, the Vivid Pioneer, featuring next-generation AI automation and enhanced imaging capabilities designed to transform cardiac diagnostic workflows. The ultra-premium system has received both CE Mark approval and U.S. FDA 510(k) clearance, positioning it for global deployment in cardiovascular care settings.
Philips has unveiled Transcend Plus, the next generation of its EPIQ CVx and Affiniti CVx cardiovascular ultrasound systems, delivering significant advancements in artificial intelligence integration and image quality enhancement.
Phraxis, Inc. has successfully completed the world’s first commercial case using its FDA-approved EndoForceAnastomotic Connector, establishing a pivotal milestone in dialysis vascular access innovation. The groundbreaking procedure, performed at Spartanburg Regional Medical Center in South Carolina, signals the beginning of U.S. commercialisation for this novel endovascular device designed to standardise arteriovenous graft creation.
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