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C2N’s Alzheimer’s test is the first to be FDA-cleared for use in patients as young as 40 who present with cognitive impairment symptoms. The post FDA clears C2N Diagnostics’ early Alzheimer’s assessment test appeared first on Medical Device Network .
Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Australia have created a point-of-care blood test capable of detecting iron deficiency within 15 minutes. The post WEHI researchers develop rapid 15-minute iron deficiency blood test appeared first on Medical Device Network .
IceCure Medical has received the JHM-IRB of West Cancer Center & Research Institute in Germantown, Tennessee, US, approval to begin patient enrolment for its post-marketing ChoICE Study. The post IceCure secures IRB approval for ChoICE Study in US appeared first on Medical Device Network .
MaxQ’s namesake platform combines advanced imaging with tissue-selective therapy in a single transurethral procedure. The post Olympus-backed MaxQ Medical raises $31.5m for prostate care platform’s advancement appeared first on Medical Device Network .
Renata’s lead product is Minima, a stent specifically designed to address congenital heart defects (CHD) in paediatric patients and young children. The post Renata Medical raises $25m to advance paediatric stent system appeared first on Medical Device Network .
Galmed subsidiary Colospan has completed a feasibility study evaluating a new intraoperative platform to assess colon tissue quality. The post Galmed’s Colospan completes feasibility study of colon tissue platform appeared first on Medical Device Network .
Empatica has received the US FDA 510(k) clearance for its Health Monitoring Platform for Parkinson’s, enabling the company to extend its clinical-grade remote monitoring technology into disease care. The post FDA clears Empatica’s platform for Parkinson’s monitoring appeared first on Medical Device Network .
The companies' programme combines their respective expertise in room-level surface sampling and building-level wastewater sequencing. The post Perimeter and Culturewell launch hospital infection surveillance programme appeared first on Medical Device Network .
Feedback on the FDA's discussion paper around regulation for GenAI-enabled medical devices is open to interested parties until October 2026. The post FDA seeks input on proposed regulatory approach to GenAI-based medtech appeared first on Medical Device Network .
Overton could take the helm at the FDA during a tumultuous period for the agency, defined by several resignations, firings and redundancies. The post Trump expected to nominate Heidi Overton as new FDA commissioner appeared first on Medical Device Network .
Danaher subsidiary Masimo has secured CE mark for its smartSedLine brain function monitor to advance anaesthetic management. The post Masimo’s brain function monitor secures CE mark appeared first on Medical Device Network .
Aqua Medical has treated the first West Coast patient in the RESTORE-I trial, a FDA-approved IDE study assessing its PIMA procedure for adults with T2D. The post First patient treated in FDA IDE study of Aqua Medical’s PIMA device appeared first on Medical Device Network .
Initially FDA-cleared in September 2024, the first clinical application of Happy Health’s smart ring is in obstructive sleep apnoea (OSA) diagnosis. The post Happy Health raises $75m for continuous healthcare platform’s expansion appeared first on Medical Device Network .
