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.
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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.
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.
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.
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.
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.
EmCyte has received 510(k) clearance from the FDA for its PurePRP Supraphysiologic concentrating system used for the preparation of platelet rich plasma concentrations.
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.
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.
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