Equipment & Devices
Equipment & Devices
Lunit Aims FDA Nod for Breast Cancer Risk Prediction Model
Lunit has gone ahead and announced the submission of a 510(k) premarket notification looking out for clearance from the US Food and Drug Administration –...
Equipment & Devices
FDA Clears Upgrade of Omnipod 5 Algorithm from Insulet
Insulet has gone ahead and secured the clearance from the US Food and Drug Administration - FDA for an algorithm advancement in its Omnipod 5...
Equipment & Devices
New Policy to Boost Medical Device Industry in China
Beijing has gone on to release a new policy so as to promote the development when it comes to the medical device industry in China,...
Equipment & Devices
US Lawmakers Push Access For AI-Powered Medical Devices
The US bipartisan legislation, which was introduced in the House on November 20, 2025, is going to designate a new temporary payment code when it comes to artificial intelligence-enabled medical...
Equipment & Devices
EU Begins Revision of Medical Device Regulatory Framework
The European Commission has gone on to initiate a call for evidence when it comes to targeted revision of Medical Device Regulation (MDR) and In...
Equipment & Devices
FDA Seeks Opinion on AI-Enabled Medical Devices Regulation
The U.S. Food and Drug Administration (US FDA) is looking out for public feedback on the regulation when it comes to AI-enabled medical devices.
The agency...
Equipment & Devices
FDA Approves Zenix Monitor-Defibrillator from ZOLL
ZOLL®, which happens to be an Asahi Kasei company manufacturing medical devices and related software solutions, announced on September 30 that Zenix®, the most clinically...
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