Up to 1,000 jobs globally could be cut over the next three years as part of a major restructuring effort following weaker first-half earnings driven by declining sales, currency pressures, and weak market demand.
Marks the first FDA-approved use of personalized molecular residual disease (MRD) testing to guide treatment decisions and solidifies Natera’s Treatment on MRD (TOMR) approach for MIBC care.
Agreement includes exclusive option to acquire novel, balloon-expandable transcatheter aortic valve made with proprietary rhenium alloy
Medtronic is overhauling its cardiovascular business in a major restructuring that includes new operating divisions, ongoing acquisitions, and a strategic push into higher-growth cardiac technologies. At the same time, the company plans to close its longtime Santa Rosa facility, affecting hundreds of employees and marking a significant shift in its U.S. manufacturing footprint. The changes come as Medtronic navigates investor pressure, intensifying competition, and a rapidly evolving cardiovascular device market.
FDA Commissioner Marty Makary says, one-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness.
The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.
PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities, according to the company Roche, will complement the company’s digital pathology portfolio to drive laboratory efficiency.
Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, people familiar with the matter said.
Health systems globally face higher utilization, tighter scrutiny, and less operational slack. As devices become more connected and service events more consequential, the limitations of generic service technology become harder to ignore.
Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in what we innovate and in how broadly those innovations can reach.