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Medtronic is spinning off its patient monitoring and respiratory interventions businesses into a new, independent entity that has yet to be named. Read More
In an effort to accelerate drug and diagnostic advances in multiple sclerosis (MS), non-alcoholic fatty liver disease and other conditions, Quest Diagnostics and Decode Health are working on a national platform for gathering and storing trial participant specimens for future RNA analysis. Read More
The FDA aims to help industry prepare responses to deficiency letters by suggesting a standardized format, the agency said in a final guidance released yesterday. Read More
The FDA has requested that Accelerate Diagnostics discontinue marketing and distribution of its Accelerate Arc system and related blood culture kit as they are not Class I devices and therefore not exempt from 510(k) clearance. Read More
Sensoria Health and Padula Research Technologies (PRT) will be presenting details of NeurOpTrek and its sock sensor tool to assess the risk of falling at the American Academy of Optometry annual meeting in San Diego, Oct. 26-29. Read More