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FDA clears C2N Diagnostics’ early Alzheimer’s assessment test

<p>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.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/fda-clears-c2n-diagnostics-early-alzheimer-assessment-test/">FDA clears C2N Diagnostics’ early Alzheimer’s assessment test</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/21/2026
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WEHI researchers develop rapid 15-minute iron deficiency blood test

<p>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.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/wehi-iron-deficiency-blood-test/">WEHI researchers develop rapid 15-minute iron deficiency blood test</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/21/2026
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IceCure secures IRB approval for ChoICE Study in US

<p>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.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/icecure-irb-approval-choice-study/">IceCure secures IRB approval for ChoICE Study in US</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/21/2026
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Olympus-backed MaxQ Medical raises $31.5m for prostate care platform’s advancement

<p>MaxQ’s namesake platform combines advanced imaging with tissue-selective therapy in a single transurethral procedure.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/olympus-backed-maxq-medical-raises-31m-for-prostate-care-platform-advancement/">Olympus-backed MaxQ Medical raises $31.5m for prostate care platform’s advancement</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/20/2026
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Renata Medical raises $25m to advance paediatric stent system

<p>Renata’s lead product is Minima, a stent specifically designed to address congenital heart defects (CHD) in paediatric patients and young children.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/renata-medical-raises-25m-to-advance-paediatric-stent-system/">Renata Medical raises $25m to advance paediatric stent system</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/20/2026
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Galmed’s Colospan completes feasibility study of colon tissue platform

<p>Galmed subsidiary Colospan has completed a feasibility study evaluating a new intraoperative platform to assess colon tissue quality.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/galmeds-colospan-completes-feasibility-study/">Galmed’s Colospan completes feasibility study of colon tissue platform</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/20/2026
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FDA clears Empatica’s platform for Parkinson’s monitoring

<p>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.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/fda-clears-empaticas-parkinsons-monitoring/">FDA clears Empatica’s platform for Parkinson’s monitoring</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/20/2026
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Perimeter and Culturewell launch hospital infection surveillance programme

<p>The companies' programme combines their respective expertise in room-level surface sampling and building-level wastewater sequencing.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/perimeter-and-culturewell-launch-hospital-infection-surveillance-programme/">Perimeter and Culturewell launch hospital infection surveillance programme</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/19/2026
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FDA seeks input on proposed regulatory approach to GenAI-based medtech

<p>Feedback on the FDA's discussion paper around regulation for GenAI-enabled medical devices is open to interested parties until October 2026.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/fda-seeks-input-on-proposed-regulatory-approach-to-genai-based-medtech/">FDA seeks input on proposed regulatory approach to GenAI-based medtech</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/19/2026
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Trump expected to nominate Heidi Overton as new FDA commissioner

<p>Overton could take the helm at the FDA during a tumultuous period for the agency, defined by several resignations, firings and redundancies.</p> <p>The post <a href="https://www.medicaldevice-network.com/news/trump-nominates-heidi-overton-fda-commissioner/">Trump expected to nominate Heidi Overton as new FDA commissioner</a> appeared first on <a href="https://www.medicaldevice-network.com">Medical Device Network</a>.</p>

8/19/2026
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