Archive

July 2026.

Field Notes

Industry roundups

Momentis Built Its Own Predicate, Then Spent It Three Times ENvue’s Feeding Tube Robot Came Second. That’s the Product Decision. How the Indication Sentence Decides Your 510(k) The Pentagon Rewrote the Drone Supply Chain. That’s a Product Requirement. Sartorius Got Its Tariff Money Back. It Handed the Refund to Customers. Vicarious Surgical Raised $425 Million and Never Reached a Submission Cepheid’s New GeneXpert Kept the Old Menu. That’s the Product. The Bearings, Not the Algorithm: Where Hardware Scale-Up Stalls J&J’s Ottava Robot Cleared FDA. Beating da Vinci Is a Different Problem The Pulse Oximeter Worked. The Validation Didn't. En Carta Signed Its Buyer Before It Built the Line Teleoperation Is a Trap Only If the Human Is There by Accident A Disposable Surgical Robot Is a Manufacturing Bet In Defense Hardware, the Constraint Is Production, Not Design For a New Implant, a Medicare Payment Code Is the Market Gate The FDA’s Review Clock Runs on FDA Days, Not Calendar Days In Orthopedic Robots, the Moat Is Never the Robot Console-Free Cryocatheter: Cutting the Console Is the Product Europe’s Biggest Fusion Raise Buys Runway, Not Fusion New Robot Safety Standards Are a Market-Access Gate, Not Paperwork Non-Surgical Brain Interfaces Win on Access. That Is Not the Hard Part. Eighty Percent of Factories Have No Robots. That Is a Product Problem. A Longer FDA Approval Clock Is a Runway Problem The First Patient-Facing Medical LLM Cleared FDA on a 510(k). The Scope Is Why. The First PTSD Neurostimulation Device Cleared FDA. Why Veterans Get It First The Pentagon’s New Drone Integrator and Your DoD Buyer Map Merck’s $11.3B Bio-Techne Deal and the Premium on Being Indispensable Launch on the Narrowest Indication You Can Defend Quantum Systems Raised $1.2 Billion. The Number to Study Is 19,000. A Cleared Device Is Not a Business: Zimmer Buys Pacira’s iovera Physical AI’s Hard Problem Isn’t Vision. It’s Knowing Where the Robot Is.
Back to archive