4 ms·
It won’t do a damn thing in the USA since it “can’t” be used for diagnosis. The incumbent industry will make sure it is not approved.
by madengr 9y ago
It won’t do a damn thing in the USA since it “can’t” be used for diagnosis. The incumbent industry will make sure it is not approved.
- rcdmd 9y agoThat's not how FDA approval works. It's actually easier for device approval when others entered the space first thanks to the "substantially equivalent" 510(k) process. Here's a link to Butterfly's premarket approval: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163510.pdf https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163510.pdf