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"Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless.
CEO Geoff Martha told investors Thursday most businesses are returning to near pre-COVID-19 growth rates, though he admitted there is "work to do" in areas like neurovascular and diabetes.
The medtech giant is recalling all Vici SDS and Vici RDS stent systems distributed over a 30-month period after receiving 17 complaints. The FDA categorized it as a Class I recall, its most serious designation.
The device industry has resolved some near term pressures as the EU's delayed landmark regulation comes into effect, but challenges related to IVDR, Brexit and more remain.
The trade group for Quest, LabCorp and others wants the Biden administration to back legislation to create a framework for laboratory developed tests separate from medical devices.
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