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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...

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...

MHRA in the UK Accelerates AI Rollout in...

The Medicines and Healthcare Products Regulatory Agency (MHRA) from the UK has established an AI commission so as to help speed up the adoption of...

FDA Widens Early Alert Initiatives for All Medical...

The Food and Drug Administration (FDA) has gone on to expand its early alert initiatives so as to cover potentially high-risk removals or even, for that matter,...

First U.S.-Based Experience Center of Siemens Healthineers

Siemens Healthineers has gone ahead and launched its first U.S.-based Experience Center in Charlotte, North Carolina, at The Pearl, Advocate Health’s innovation district to address...

Medical Devices Leveraging Robotic Surgical Instruments

Medtronic stated that the expansion of its office in London is going to create the largest global digital center of the company that’s related to...

MedTech Europe Seeks Regulatory Changes From the EU

MedTech Europe seeks regulatory changes and has urged the European Commission to act in a swift way and offer regulatory relief to the device as...

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