That'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)

That'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