Web2. level 1. ididacannonball. · 5 mo. ago. From my understanding, they were in a regulatory no-man's land so to say. They were not using the devices to perform the tests in people's homes or even at remote sites, which would necessitate FDA approval. Instead, all samples were being shipped to their lab and "tested". WebJan 14, 2024 · Testing companies are not required to seek US Food and Drug Administration (FDA) approval if they use their tests only at their own laboratories, as Theranos did. These so-called laboratory-developed …
Was Theranos approved by CSM, FDA or both? - Medical Devices …
Web19 hours ago · The panel's decision came just days after the Justice Department swiftly appealed a far-reaching ruling last week out of Texas, when a federal judge blocked the FDA’s approval of the pill ... WebJan 29, 2024 · Theranos’s test for detecting herpes simplex virus 1 is approved by the Federal Drug Administration (FDA). But by December, the test has come under scrutiny. This is the only Theranos test to be ... haverlah plz
How Theranos’ faulty blood tests got to market - The …
WebMar 14, 2024 · 6. Holmes said that Theranos didn’t need to get FDA approval. It did. From 2013 to 2015, Holmes repeatedly told potential investors that Theranos didn’t need … Web” For example, he mentioned that his company, Sight Diagnostics, was intent on quickly gaining FDA approval, which Theranos apparently attempted to put off, and has been far more open with... WebApr 10, 2024 · uhhh fda being difficult lately with the device category.. should be easier.. hmmm.. they going denovo as well which is strange cuz a "predicate" device already exists. might have to just go "rando" when all the .30s start poppin :) havilah map