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At this year’s Healthcare Information and Management Systems Society (HIMSS) 2022 conference in Orlando, Fla., digital health companies across the sector gathered to showcase new products and services. HIMSS CEO Hal Wolf urged the industry to focus on global health equity and a 2022 survey of health care leaders highlighted the elements of digital transformation that are causing the biggest buzz.
Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.”
In a lively discussion at the 40th annual J.P. Morgan Healthcare Conference, panelists from leading diagnostics companies debated the best way to screen for cancer – and whether diagnostic testing does more harm than good in some circumstances. Kevin Conroy, CEO of Exact Sciences Corp., noted that he expected liquid biopsies to have an “enormous impact on making earlier cancer detection a routine part of medical care” with his company currently developing a blood-based test for colon cancer as well as a multicancer test and one for minimal residual disease.
Intuitive Surgical Inc. benefited from keen interest in resuming surgeries during pandemic troughs and hospitals investing in its Da Vinci robotic system in preparation for a more endemic phase of COVID-19, Intuitive CEO Gary Guthart said in a presentation at the J.P. Morgan 40th Annual Healthcare Conference on Jan. 12. The company’s unaudited preliminary fourth quarter and full year 2021 results also showed strong growth in procedure volumes – 19% year-over-year compared to 2020 and 13% compared to 2019. Still, Intuitive reported that “during 2021, COVID-19 resurgences continued to impact Da Vinci procedure volumes. The impact of the COVID-19 pandemic on the company’s business has, and continues to, differ by geography and region.”
A panel of leaders in women’s health at the 2022 edition of the J.P. Morgan Healthcare Conference addressed the challenges and benefits of digital health and new apps in enabling women to be the “chief medical officers” of their families’ health and to take the necessary steps to improve their own. The panel included moderator Lynne Chou O’Keefe, founder and managing partner of Define Ventures; Apple Inc.’s Vice President of Health Sumbul Ahmad Desai; Veronica Gillispie-Bell, assistant professor, Ochsner Health System; Found CEO Sarah Jones Simmer; Michelle Williams, dean of faculty at the Harvard T.H. Chan School of Public Health; and Tia Inc. CEO and co-founder Carolyn Witte.
Digital health innovation was front and center at this year’s Consumer Electronic Show (CES) in Las Vegas. The four-day event included a major product announcement from Abbott Laboratories and a keynote presentation delivered by CEO Robert Ford. This marked the first time a health care company has been invited to take the mainstage.
The Verifying Accurate Leading-edge IVCT Development (VALID) Act seems poised for passage in 2022, a bit of welcome relief for those stuck in the regulatory twilight world of the lab-developed test (LDT). However, Carly McWilliams, director of regulatory policy for North America for Roche Inc., said recently at the recent Food and Drug Law Institute enforcement meeting that the VALID Act is likely to leave the question of a user fee schedule for a future Congress, given that the associated rulemaking, guidance development and compliance activities are likely to consume the better part of, if not the entirety of, the next five years.
Two studies presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference directly compared Boston Scientific Corp.’s Watchman 2.5 and Watchman Flx to Abbott Laboratories’ Amplatzer Amulet device. Both showed Amulet had less than half as many leaks, but the clinical impact of the lower rate remained unclear.
Catheter-based delivery of replacement valves is established practice for patients with aortic regurgitation, but the mitral valve has only repair devices to address this condition. However, transcatheter mitral valve replacement (TMVR) devices by Dublin-based Medtronic plc., and triscupid valve replacement devices by Edwards Lifesciences Inc. of Irvine, Calif., made some noise at this year’s edition of Transcatheter Cardiovascular Therapeutics (TCT), suggesting that these patients might soon have a wider range of options.
It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?