How MedTech manufacturers can move cybersecurity upstream, strengthen traceability, and prepare for faster vulnerability response.
GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.
Artivion has finalized its acquisition of Endospan Ltd., adding the FDA-approved NEXUS Aortic Arch System to its portfolio of aortic arch therapies. The deal strengthens the company’s position in the growing endovascular aortic repair market and adds a pipeline of next-generation arch technologies.
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
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
Edwards announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue.
The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J’s expanding cardiac ablation business.