Knowledge Bank
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,...
Imaging & Diagnostics
GE HealthCare Expands AI Mammography Partnership with RadNet
GE HealthCare has widened its collaboration with RadNet subsidiary DeepHealth, advancing efforts to accelerate the development and deployment of AI mammography solutions. The announcement aligns...
Equipment & Devices
EMA Pilot to Fast-Track Breakthrough Medical Devices in EU
The European Medicines Agency is set to introduce a pilot programme in the second quarter of 2026 aimed at advancing support for breakthrough medical devices...
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