Author name: Leonardo Arias

The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.

The company hopes to launch its next-generation Watchman system in the second half of 2027 or early 2028.

Despite repeated warnings from telehealth groups, Congress failed to extend the pandemic-era telehealth policies before they lapsed on Oct. 1. Now, providers are scrambling to manage the disruption to virtual care reimbursement and access.

At the heart of the agreement is Pfizer’s $70 billion commitment to U.S.-based manufacturing and an exemption from tariffs for three years. While the reaction was mostly positive from Wall Street, other observers noted that the benefits for patients are unclear at best.

The medical device industry has a jam-packed year of events for professionals to attend, including the J.P. Morgan Healthcare Conference, DeviceTalks Boston and AdvaMed’s annual medtech meeting.

As with recent rejections for Biogen and Scholar Rock, manufacturing issues stymied a regulatory bid from Fortress Biotech and Sentynl Therapeutics. Fortress said the FDA did not flag problems with the drug’s safety or efficacy.

Novo Nordisk and Heartseed first partnered in 2021 to develop an investigational cell therapy for heart failure.

The first oral BTK blocker for chronic spontaneous urticaria, Rhapsido offers a more convenient treatment option for patients who still show symptoms after antihistamine treatment.

The business separation, expected to be completed by the end of 2026, will result in two new companies, one focused on biopharma operations and the other on royalty management.

These are the events healthcare leaders should plan for next year, covering topics like digital health, rural care and financial management.