Better Diagnostics AI Corp. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Better Diagnostics Dental Assist (BDDA) Version 1.0510(k)Jul 15, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 15, 2026
Better Diagnostics Caries Assist (BDCA) Version 1.0510(k)Mar 11, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 11, 2025