Equipment & Devices
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...
Equipment & Devices
FDA Widens Early Alert Initiatives for All Medical Devices
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,...
Equipment & Devices
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...
Equipment & Devices
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...
Equipment & Devices
FDA Withdraws Rule Regulating Laboratory-Developed Tests
In a move that has indeed led to many discussions, the Food and Drug Administration (FDA) released a final rule on September 18 that cancels...
Equipment & Devices
Siemens Healthineers & Stryker Come Together to Develop Neurovascular Robotic System
Siemens Healthineers, the German healthcare company, and Stryker, which is the US-based medical device maker, have collaborated to advance the robotic systems for neurovascular interventions.
This...
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