The U.S. FDA has finally unveiled the framework for the software precertification pilot program, and has incorporated elements of the de novo premarket program to deal with what some critics said was an extralegal proposal to limit premarket scrutiny of software as a medical device (SaMD) to an appraisal of a developer's culture of excellence. The problem with this new approach is that it would simultaneously impose a pre-cert requirement and a traditional de novo premarket review, seemingly a more cumbersome approach to digital regulation than the agency had promised.

SAN FRANCISCO – It's quite difficult to maintain rapid growth as a company gets very large, since it takes more to move the needle on an increasingly bigger revenue base. But continuous glucose monitor (CGM) player Dexcom Inc. has managed to do just that so far – and its being richly rewarded by Wall Street for its performance and expectations going forward.