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.
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.
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
The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J’s expanding cardiac ablation business.
The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.