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.
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.
Without formal policies and governance, MedTech organizations face risks to intellectual property, product quality, and ultimately patient safety. Thoughtful AI governance enables development teams to capture efficiency gains while maintaining the rigor that the industry demands.
Healthcare environments are dynamic with patient populations, clinical practices and data collection methods continuously evolving. Similarly, effective AI systems depend on more than performance at initial deployment. They must be monitored and managed throughout their lifecycle to remain reliable, clinically relevant, and safe.
Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally Invasive Cardiac Surgery (MICS) and robotic cases.
SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach
Edwards announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue.
Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?
Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are effective, safe, compliant, and trustworthy.
No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.
