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Brainlab Receives FDA Clearance For Imaging Robot, Alignment Module For Spine

 
• By Marion Webb

Brainlab is expanding its digital surgery portfolio with the FDA clearance for imaging and alignment module systems.

Cirq robotic arm

Brainlab AG announced on 22 February it received US Food and Drug Administration clearance for its Loop-X Mobile Imaging Robot and Cirq robotic alignment module for spine surgery.

Loop works with the company’s Brainlab digital surgery portfolio and can be integrated with customers’ existing surgical setups, according to...

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Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems

 
• By Marion Webb

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‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
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FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

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