Category: Diagnostics
Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System
Boston Scientific has been granted FDA 510(k) clearance for their LUX-Dx insertable cardiac monitor system. This long-term diagnostic device is used to detect arrhythmias from conditions such as atria... Read More
Beckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test
Beckman Coulter has been granted Emergency Use Authorization by the FDA for its new COVID-19 antibody test. This approval comes after being tested by the top four in vitro diagnostic manufacturers in ... Read More
Abbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor
The most recent integrated continuous glucose monitor (iCGM) from Abbott, the Freestyle Libre 2, has been granted FDA approval for sale in the U.S. to adults and children over the age of four with dia... Read More
Medtronic Recalls MiniMed Insulin Pumps for Incorrect Dosages
Medtronic has recalled the MiniMed 600 Series Insulin Pumps due to missing or broken retainer rings resulting in incorrect insulin dosages. The MiniMed Insulin Pumps are designed to administer proper ... Read More
New Siemens Angiography Systems get FDA Clearance
Register to receive a free U.S. Medical Imaging Market Analysis, Size, and Trends Report synopsis and brochure. In a recent success for Siemens Healthineers, their ARTIS icono angiography systems ha... Read More
Typenex Medical Brings Innovative Blood Irradiation Indicator to Market
Typenex Medical, an industry leader in medical devices and supplies, recently announced it is bringing Rad-Control, a new irradiation indicator tag technology, to blood banks and blood centers in the ... Read More- 2 of 2
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