Harnessing post-market surveillance with real world data This session will explore what data sources are available, how we assess the need for new evidence, where innovations are happening and how this data can help maximize patient safety. It will help shift the paradigm of recall management from reactive to proactive. Register now.
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 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.
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.
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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