Fujifilm colonic polyp detection device gets CE mark | Q4 revenue rises to $810.8M for BioMerieux | Financing round pulls in $18M for Viseon
February 27, 2020
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Top Story
European regulators have granted CE mark approval to Fujifilm's CAD EYE system, an artificial intelligence-run device used during colonoscopy procedures to detect colonic polyps.
Full Story: FDAnews (2/26) 
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Business & Market Trends
BioMerieux posted revenue of $810.8 million during the fourth quarter of 2019, up 11% from the previous year. The company noted 20% growth for its BioFire FilmArray line, with approximately 600 units installed.
Full Story: 360Dx (tiered subscription model) (2/26) 
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Spinal surgery device maker Viseon has raised $18 million in a round of Series B financing. The funds will be used for regulatory approvals worldwide, commercialization, clinical evaluations, manufacturing scale-ups and product development.
Full Story: Verdict Medical Devices (UK) (2/26) 
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Science & Health
Researchers from the California Institute of Technology have developed a noninvasive wearable sensor to detect cortisol level changes using sweat. Study results were published in the journal Matter.
Full Story: MedGadget (2/26) 
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Emerging Technologies
Researchers from Monash University in Australia have developed a wearable blood pressure monitor, which uses continuous wave radar and photoplethysmogram sensors attached to the earlobe and sternum, to measure pulse transit time, pulse arrival time and pre-ejection period to calculate systolic blood pressure.
Full Story: HospiMedica International (free registration) (2/26) 
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Government & Regulatory
The FDA has announced its plans to test a pilot program using a new 510(k) template called eSTAR, or electronic Submission Template and Resource, which is interactive, PDF-based, and has a structure compatible with the internal review templates of the Center for Devices and Radiological Health.
Full Story: Regulatory Focus (2/26) 
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EmCyte has received 510(k) clearance from the FDA for its PurePRP Supraphysiologic concentrating system used for the preparation of platelet rich plasma concentrations.
Full Story: FDAnews (2/26) 
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The FDA has given CHF Solutions' next-generation Aquadex SmartFlow console 510(k) clearance. The device is intended for use on pediatric and adult patients weighing 20 kilograms and above to drain excess fluids caused by hypervolemia.
Full Story: MassDevice (Boston) (2/27) 
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Ortho Clinical Diagnostics' Vitros XT 3400 Chemistry System has been given CE mark approval. The system is a part of the company's Vitros XT Solutions.
Full Story: 360Dx (tiered subscription model) (2/26) 
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Join us on April 23-24, 2020 for the 13th Annual Medical Devices and Diagnostics Statistical Issues Conference in Washington, DC. This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. Learn more.
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