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The Intelligence Layer
of Surgery
Explore how real time data, robotics, and AI are transforming the operating room from smarter decisions at the table to safer recoveries after surgery.
What the FDA Wants Surgical Robots to Prove
The FDA's September 2026 draft guidance lists the testing and clinical evidence surgical robots should show and leaves autonomous systems out.
15 hours ago3 min read
97 FDA-Cleared Surgical AI Devices: What They Actually Do
97 AI-enabled surgical devices have FDA clearance through June 29, 2026. See how they split across navigation, planning, endoscopy and robotics.
7 days ago3 min read
Da Vinci 5 vs Hugo vs Ottava: What Their 2026 FDA Clearances Mean
Da Vinci 5, Hugo, and Ottava each secured a different FDA clearance in the same eight months. Here's how the operating room split three ways in 2026.
Sep 183 min read
SportSuite Vision Becomes the First FDA-Authorized OR App for Apple Vision Pro
Stryker's SportSuite Vision earned FDA De Novo authorization for Apple Vision Pro and completed its first hip arthroscopy case at Duke Health.
Sep 31 min read
How Many AI Medical Devices Are FDA Cleared? What the Evidence Shows
A PLOS Digital Health review of every FDA-cleared AI medical device finds a validation gap running straight through the OR, including anesthesiology and surgical planning tools.
Aug 312 min read
Aletta's FDA Authorization Sets the Bar Other Robotic Blood-Draw Devices Must Clear
The FDA authorized Vitestro's Aletta through the De Novo pathway on August 19, 2026, creating special controls for robotic phlebotomy. Peer-reviewed data show a 94.5% first-stick success rate.
Aug 242 min read
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