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With surgeons using robotically assisted surgical devices in new ways, the FDA wants more information on how to best assess these tools to ensure the safety of patients while enhancing innovation. Read More
Members of the World Trade Organization have signed a $1.3 trillion trade deal that would eliminate tariffs on more than 200 information technology products, including pacemakers and other essential medical devices. Read More
Patient labeling for medical devices will take center stage at a September FDA workshop as the agency considers updating industry guidance on the topic. Read More
Following 45 reports of serious adverse events, the FDA is cautioning healthcare providers about using a SentreHeart device in a procedure intended to prevent strokes. Read More
Malaysia’s Medical Device Authority has extended the application deadline for medical device manufacturers to register their products in that country. Read More
The FDA is giving labelers of intraocular lenses the green light to restart submissions to the Global Unique Device Identification Database after extending the deadline by one year over data concerns. Read More
Top FDA officials last week listened to stakeholder feedback on what has worked well and what can be improved in the Medical Device User Fee Amendments. Read More