MedTech Industry Dynamics
MedTech Industry Dynamics
Philips has launched UniGuide 3D Live Guidance in Europe and other CE-marked markets, a solution that integrates CT-derived insights and pre-procedural treatment planning directly into the live Azurion workflow to support informed, patient-specific decisions during interventional procedures.
Read MoreVygon has obtained CE marking and UKCA authorization for its Stiletto next-generation extended-dwell peripheral catheter equipped with SlipStream technology, enabling rollout across a number of European countries for courses of treatment averaging less than 28 days.
Read MoreAbbott has received CE Mark under the EU In Vitro Diagnostic Medical Devices Regulation for its Cologuard Plus stool-based DNA screening test, which detected 95% of colorectal cancers at 94% specificity in the pivotal BLUE-C study, marking a step toward bringing the noninvasive test to European markets.
Read MoreMedtronic has received CE Mark for its Vitalis portfolio of cardiac devices, including the ReSyncra CSP, Restoria CSP, Refina CSP, Effectra, and Confirma pacemakers, offering a suite of pacing options with features purpose-built for conduction system pacing therapy.
Read MoreMedtronic has received FDA clearance and CE Mark for its Affera Prism-2 Mapping Software, along with CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software, expanding integrated mapping and tissue-proximity capabilities across its cardiac ablation portfolio.
Read MoreIntuitive has received CE mark approval for its da Vinci 5 surgical system in adult cardiac surgery in Europe, including thoracoscopically-assisted cardiotomy and minimally invasive coronary artery bypass procedures, marking the company’s re-entry into robotic-assisted cardiac surgery in the region.
Read MoreRevvity has launched the GSP T1D 3plex kit, a fully automated, CE-IVDR-certified multiplex autoantibody detection solution using dried blood spots for scalable sample collection, designed to enable population-wide screening programs that identify children at risk of type 1 diabetes before symptoms appear.
Read MoreIntuitive has received CE mark approval for transvaginal gynecologic procedures with the da Vinci SP surgical system, marking a world’s-first indication for the single-port platform and expanding its CE-marked applications in Europe.
Read MoreLifeTech Scientific has received CE MDR certification for its Yuranos abdominal aortic stent graft system, designed for endovascular repair of infrarenal abdominal aortic aneurysms and compatible with the company’s G-iliac and SilverFlow stent systems for complex cases involving iliac artery involvement.
Read MorePulsenmore has completed CE registration under the European MDR for its Pulsenmore FC home ultrasound system for follicular monitoring during IVF and fertility preservation, marking the company’s second authorized product in Europe and its expansion beyond prenatal care into women’s health.
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