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. Read More
HAMBURG, Germany – Startup company Pq Bypass Inc. has completed a round of funding that can provide up to an aggregate of $60 million in equity financing to be used to advance clinical develop of its Detour system, which treats long blockages in leg arteries caused by peripheral arterial disease. The goal of the company is to eventually win U.S. FDA clearance for the system. Read More
SAN FRANCISCO – Fingerstick-free continuous glucose monitors (CGMs) are a fast-growing segment, where Abbott has a first mover advantage. Dexcom Inc., of San Diego, gained its own label last year on this front and took the J.P. Morgan Healthcare Conference to highlight the perceived advantage of its G6 system over Chicago-based Abbott Laboratories' Freestyle Libre. These include the need for actively, rather than passively, gathering blood glucose data and the absence of alarms. Read More
SAN FRANCISCO – The question of the possibilities of artificial intelligence (AI) took center stage at the Digital Medicine and Medtech Showcase being held during J.P. Morgan Week, with members of the community marking the official launch of the Alliance for Artificial Intelligence in Healthcare (AAIH). Read More
In a fast-paced J.P. Morgan interview that traversed much of the drug and device landscape, FDA Commissioner Scott Gottlieb discussed a busy agenda Tuesday as he committed the agency to keeping up with innovation, speeding competition and pacing the opioid epidemic. Read More
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. Read More
