Industry Updates
Johnson & Johnson to Acquire Atraverse Medical Platform
Johnson & Johnson has entered into a definitive agreement to acquire Atraverse Medical, bringing the developer of a novel transseptal access platform into its cardiovascular...
Equipment & Devices
US Speeds Insurance Coverage for Breakthrough Medical Device
A new federal initiative in the United States is set to significantly shorten the timeline for securing insurance access to advanced medical technologies, addressing a...
Equipment & Devices
FDA Flags Nitrosamine Impurity Risk in Combination Products
The U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), has issued a formal communication to manufacturers of CDRH-led...
Imaging & Diagnostics
FDA 510(k) Clearance Granted to Philips Rembra Platform
Philips has secured FDA 510(k) clearance for its Rembra platform of scanning systems, marking a regulatory milestone for its latest computed tomography technologies. The clearance...
Equipment & Devices
BVI Virtuoso Receives CE Mark for Dual Eye Surgery System
BVI Medical has secured CE Mark certification under the European Union Medical Device Regulation (EU MDR) for its Virtuoso platform, positioning the system for commercial...
Imaging & Diagnostics
Johnson & Johnson Advances Cardiac Mapping with AI Module
Johnson & Johnson has outlined plans to introduce a new artificial intelligence-enabled module within its cardiac mapping ecosystem, reinforcing its long-standing focus on electrophysiology innovation....
Imaging & Diagnostics
Philips Spectral CT Verida Secures FDA Clearance Approval
Philips has secured FDA 510(k) clearance for its AI-powered Spectral CT Verida system, marking a significant step in advancing imaging capabilities. Introduced in December 2025,...
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