SAN FRANCISCO – Imaging giant GE Healthcare is slated to spinoff from its parent company in an IPO. It reportedly filed confidentially with the SEC in mid-December and is slated to make its independent public debut in mid-2019. (See BioWorld MedTech, June 27, 2018.) Given this, the company opted to update investors at the J.P. Morgan Healthcare conference, although it avoided any discussion of the public offering or detailed financials.

SAN FRANCISCO – The name of the game thus far for Guardant Health Inc. has been precision medicine, using genomics to select the best therapy particularly for advanced cancer patients. But it's moving further into cancer recurrence monitoring – and even, ultimately, the Holy Grail of a liquid biopsy for cancer screening.

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.

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.

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).

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.

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.