In response to the COVID-19 pandemic, health systems around the world are looking to digital technologies to support health delivery but where exactly can these technologies have the most impact? At the Medtech Forum in Barcelona, European leaders gathered to discuss practical examples of how digital tools can help make health systems more efficient.

The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is flexible on the proposed one-year implementation deadline. However, Shuren also noted that the draft rule would not be converted into a final rule at any point during the current calendar year, leaving device makers with an extended term of uncertainty.

As was the case with left atrial appendage closure, renal denervation (RD) as a treatment for hypertension has proven to be difficult to move along into routine clinical usage. New data for a study sponsored by Medtronic plc showed that RD offers a statistically significant improvement over sham treatment in reducing hypertension, but the data do not seem to suggest that patients will be able to drop their antihypertensive medications after RD treatment.

The tricuspid valve at times seems the lost child of the heart’s valves, but new research hints that regurgitation of this valve can be resolved with a transcatheter replacement. Adam Greenbaum, of Emory University School of Medicine, said the early feasibility study of the Pascal valve by Edwards Lifesciences Inc., of Irvine, Calif., demonstrated a large improvement in mortality at one year and significant improvements in heart failure status, a result that offers new hope for these patients.

There has been some skepticism about the value of electronic health records (EHRs) beyond their role as a source of income for EHR developers, but an April 3 presentation at the 2022 America College of Cardiology scientific sessions being held in Washington suggests this type of software offers some real value for heart failure patients. Tariq Ahmad of Yale School of Medicine said a study of EHRs suggests their power lay in part in prompting compliance with heart failure medication regimes, an application of this type of software that can both save lives and cut costs for the Medicare program and Medicare beneficiaries.

Pharmaceutical agents took center stage in Washington on the first full day of the 2022 scientific sessions of the American College of Cardiology, such as an April 2 presentation on the use of the mavacamten for obstructive hypertrophic cardiomyopathy (OHC). Milind Desai of the Cleveland Clinic said 16-week data for this cardiac myosin inhibitor showed well in reducing heart failure class status, but there are data arising from studies in China which suggest that radiofrequency (RF) ablation might also work for these patients.

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.”