"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.
| Social distancing mandates ramped up interest in delivering healthcare online.
| 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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