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Exogenesis’ nanoMesh hernia repair device caused less inflammation than a control implant mesh during evaluations 14 and 28 days after implant, the company says. Read More
The Department of Health and Human Services (HHS) said Wednesday it will spend $650 million in American Rescue Plan funds to strengthen manufacturing capacity for COVID-19 diagnostics, through rapid point-of-care molecular tests, and to increase public access to them. Read More
Meridian Bioscience’s Revogene test for COVID-19 can return a positive result as soon as within 47 minutes from nasopharyngeal, oropharyngeal, anterior nasal and midturbinate nasal swab specimens. Read More
HeartVista’s One Click MRI features real-time automated analysis of regional wall motion as part of cardiac function assessment, registration of perfusion images for easier visual defect detection, enhanced T1-mapping for cardiomyopathy analysis and dedicated septal T1-mapping for myocarditis. Read More
One of the complaint unit’s chief responsibilities is to maintain complaint files, which are the records documenting all analysis conducted and actions taken when a company receives a complaint about a device. Read More
As part of a major reorganization, General Electric is spinning off its GE Healthcare division as a publicly traded company, the corporation announced this week. Read More
Device trade association AdvaMed has told the federal government that the worldwide shortage of semiconductors continues to create major problems for the industry. Read More
The reason for the recall of certain lots of Ellume’s COVID-19 Home Tests, totaling more than 2.2 million individual tests in all, is that they have a higher-than-acceptable rate of false-positive test results. Read More
There have been 42 reports of plunger retraction and introduction of air into the Cardinal Health syringes, which are included in Windstone’s custom convenience kits, but no reports of complaints, injuries or deaths. Read More
The nView s1 can take 3D images on the fly during surgery and surgeons can navigate them immediately, according to nView medical CEO Cristian Atria. Read More