Field Notes Archive

September 2026 14 entries Sep 15 When No Law Fits Your Product, Regulators Reach for the Nearest One Sep 14 J&J Bought Into a $37 Billion Orthopedics Market. It's Leaving a $50 Billion One. Sep 13 GM Is Building Battery Cells It Will Never Sell So It Can Judge the Ones It Buys Sep 12 Teradyne Is Suing Over Three Universal Robots Patents. All Three Expire in March. Sep 11 Axogen Paid $200 Million to Widen the Pool of Surgeons Who Can Repair a Nerve Sep 10 Nine Sites, $1.8 Million: How to Read a Hardware Company's Traction Sep 8 The Army Bought Its First Production Laser. The Factory Was Funded in March. Sep 7 Cellares' Machine Met Every Release Spec. Bristol Myers Squibb Still Walked Away. Sep 6 Stryker's Surgical Headset Is FDA Authorized. Its Own Label Keeps the Monitors On. Sep 5 Medtronic Paid $700 Million for a Surgical Robot It Can't Sell in the United States Sep 4 FDA Reclassified This Cancer Test Category. Fewer Than Five People Commented. Sep 3 Kardium's Cleanroom Builds 500 a Year. The Business Needs 30,000. Sep 2 Two in Ten Storage Projects Now Treat the 30% Tax Credit as Optional Sep 1 Boston Scientific Is Pulling Catheters Its Complaint Data Never Flagged

August 2026 32 entries Aug 31 Oura Says It Isn't a Medical Device. The Ad Compared It to a Sleep Lab. Aug 30 The FDA Wants to Know How You'd Test a Device That Answers Differently Every Time Aug 29 Medtronic Pulled These Capsules Twice for the Same Failure. Only the Cause Changed. Aug 28 Bedrock’s Excavators Dig With Nobody in the Cab. Bedrock Doesn’t Build Excavators. Aug 27 Uber's Software Decided Who Kept Earning. The Missing Human Cost 825 Million Euros. Aug 26 Boston Scientific's Plants Went Quiet. Its Filing Names Shipping, Not Devices. Aug 25 XPeng Raised $900 Million for a Humanoid. Its First Customer Is XPeng. Aug 24 Every COVID-19 Test EUA Ends December 26. Authorized Was Never the Same as Cleared. Aug 23 The FDA's TEMPO Pilot Isn't Reviewing These Devices. The Companies Wrote Their Own Limits. Aug 22 ARPA-H Bet $175 Million on Autonomous Stroke Robots. The Hard Part Is the Room They Land In. Aug 21 The FDA Authorized a Blood Draw Robot. The Ratio in the Label Is the Product. Aug 20 GM Walked Away From This Battery Plant Twenty Months Before It Opened Aug 19 The Navy Wants Sixteen Times the Tomahawks. The Seven Years Is What Buys Them. Aug 18 J&J Cleared AI on Its Lung Robot. The Fourth Update in Eighteen Months Matters More. Aug 17 Abbott Makes the Glucose Number. Google Charges for What to Do About It. Aug 16 H.B. Fuller Already Made Surgical Glue. It's Paying £715 Million for the Evidence. Aug 15 The Medicare Coverage Decision Now Happens Before Your Pivotal Trial Aug 14 Cook Medical's Breach Never Touched the Device. It Went Through a Person. Aug 13 Joby Is Paying $500 Million to Move Its Defense Work Out of the Building Aug 12 Hadrian Raised $1.37 Billion for Factories. The Drawings Are Still Your Problem. Aug 11 iRhythm Paid $287.5 Million to Stop Waiting on Its Own FDA Clearance Aug 10 Caristo Built a Heart Test for the Patients Who Get Sent Home. The Billing Codes Came First. Aug 9 HII Put $900 Million on the Table for Shipyard Robots. The Qualification Comes First. Aug 8 An FDA Advisory Panel Reads Your File Cold. Grail Finds Out September 23. Aug 8 An FDA Advisory Panel Reads Your File Cold. Grail Finds Out September 23. Aug 7 Solventum Is Separating $1.4 Billion of Software. It Ran on a Different Clock. Aug 6 BD's Needle Was Out of Tolerance for Twenty Months. Part of the Fix Is a Label. Aug 5 The Pentagon Wants Four Times the THAADs. The Shopping List Says Muzzle Covers. Aug 4 Reimagine Wants Your Line Worker to Teach the Robot. Walden Wants to Do It for You. Aug 3 Walter Reed Cleared the Implant. Now the Hospital Is the Manufacturer. Aug 2 MMI Didn't Build a Robot for Alzheimer's. Two Surgeons Decided It Was One Anyway Aug 1 Peak Energy Picked the Weaker Chemistry. Then It Deleted the Cooling System.

July 2026 31 entries Jul 31 Momentis Built Its Own Predicate, Then Spent It Three Times Jul 30 ENvue’s Feeding Tube Robot Came Second. That’s the Product Decision. Jul 29 How the Indication Sentence Decides Your 510(k) Jul 28 The Pentagon Rewrote the Drone Supply Chain. That’s a Product Requirement. Jul 27 Sartorius Got Its Tariff Money Back. It Handed the Refund to Customers. Jul 26 Vicarious Surgical Raised $425 Million and Never Reached a Submission Jul 25 Cepheid’s New GeneXpert Kept the Old Menu. That’s the Product. Jul 24 The Bearings, Not the Algorithm: Where Hardware Scale-Up Stalls Jul 23 J&J’s Ottava Robot Cleared FDA. Beating da Vinci Is a Different Problem Jul 22 The Pulse Oximeter Worked. The Validation Didn't. Jul 21 En Carta Signed Its Buyer Before It Built the Line Jul 20 Teleoperation Is a Trap Only If the Human Is There by Accident Jul 19 A Disposable Surgical Robot Is a Manufacturing Bet Jul 18 In Defense Hardware, the Constraint Is Production, Not Design Jul 17 For a New Implant, a Medicare Payment Code Is the Market Gate Jul 16 The FDA’s Review Clock Runs on FDA Days, Not Calendar Days Jul 15 In Orthopedic Robots, the Moat Is Never the Robot Jul 14 Console-Free Cryocatheter: Cutting the Console Is the Product Jul 13 Europe’s Biggest Fusion Raise Buys Runway, Not Fusion Jul 12 New Robot Safety Standards Are a Market-Access Gate, Not Paperwork Jul 11 Non-Surgical Brain Interfaces Win on Access. That Is Not the Hard Part. Jul 10 Eighty Percent of Factories Have No Robots. That Is a Product Problem. Jul 9 A Longer FDA Approval Clock Is a Runway Problem Jul 8 The First Patient-Facing Medical LLM Cleared FDA on a 510(k). The Scope Is Why. Jul 7 The First PTSD Neurostimulation Device Cleared FDA. Why Veterans Get It First Jul 6 The Pentagon’s New Drone Integrator and Your DoD Buyer Map Jul 5 Merck’s $11.3B Bio-Techne Deal and the Premium on Being Indispensable Jul 4 Launch on the Narrowest Indication You Can Defend Jul 3 Quantum Systems Raised $1.2 Billion. The Number to Study Is 19,000. Jul 2 A Cleared Device Is Not a Business: Zimmer Buys Pacira’s iovera Jul 1 Physical AI’s Hard Problem Isn’t Vision. It’s Knowing Where the Robot Is.

June 2026 29 entries June 30 Medtronic’s Hugo Filing Is an Access Play, Not a Specs Fight June 29 Aidoc’s Radiology AI Got a Breakthrough Tag, Not a Clearance June 28 Why the FDA’s 2,200 New Hires Won’t Speed Up Your Review June 27 Tissium’s $68M Raise and the Power of a Narrow De Novo June 26 Energy Dome’s CO2 Battery Wins Where Lithium Can’t June 25 Why a 3-Hour-Faster Blood Culture Test Is a Real Product June 24 What FDA’s QMSR Transition to ISO 13485 Means for Founders June 23 Karl Storz Is Retiring a Surgical Robot That Worked June 22 Medtronic’s Pulse Oximeter Fix Began in the Cohort June 21 When Beating the Predicate Breaks Your 510(k) June 20 The FDA’s Former Device Chief Is Advising Startups. What That Actually Buys You June 19 Sanctuary AI’s Physical AI Claim Is One You Can Actually Check June 18 How to Read the Pentagon’s Drone-Budget Surge as a Hardware Founder June 17 How a 2018 De Novo Let Dexcom Put a Glucose Monitor on a Toddler June 16 Why OraSure Built a Collection Kit, Not a Better STI Test June 15 GT Medical Raised $100M on Evidence, Not the Clearance It Already Had June 14 The Robot Is the Giveaway. The Instruments Are the Business. June 13 NEURA’s $1.4 Billion Humanoid Bet. I’d Bet Narrow. June 12 Penumbra’s Thunderbolt Stroke Clearance Is a Platform Play June 11 Battlefield Drone Tech Came Home. The Dual-Use Line Is the Lesson. June 10 GM’s Sodium-Ion Bet: Why It’s Selling Cells, Not Systems June 9 When a Quality System Catches the Problem and Still Can’t Fix It June 8 The 2026 Hardware Funding Records Hide a Higher Bar, Not Easier Money June 7 Medicare’s RAPID Coverage Pathway Moves the Work Earlier for Device Founders June 6 FDA 510(k) Exemptions Are Expanding. They Can Erase Your Moat June 5 Closed-Loop Insulin Delivery: The Algorithm Is the Easy Part June 4 The Humanoid Robot Is the Most Photogenic Bet in Physical AI, and the Hardest to Ship June 2 The Pentagon’s Drone Gauntlet Is Really a Manufacturing Test June 1 Spectral AI’s De Novo Clearance Is a Lesson in Non-Dilutive Capital

May 2026 31 entries May 31 A Narrow Indication Is the Regulatory Strategy for AI Medical Devices May 30 The Climate-Hardware IPO Wave Is a Demand Story, Not a Technology Story May 29 Surgical Robotics’ Real Edge in 2026 Is Knowing When Not to Launch May 28 The Neurosurgical Supply Shortage Reveals the Hidden Risk in Your DHF May 27 MDUFA VI Just Reset the De Novo and Pre-Sub Mechanics May 26 Physical AI’s Big Checks Are Landing Above the Robot May 25 Deal Team Six Rewrites the Defense Hardware Founder’s Path to Market May 24 Software Cadence Is Becoming the Surgical Robotics Moat May 23 Medtronic’s $650M SPR Deal and the Chronic Pain Platform Consolidation May 22 Guardant360 Liquid CDx and the Companion Diagnostic Platform Moat May 21 The Surgical Robotics Challenger Field Fills Out in 2026 May 20 Boston Scientific’s SEISMIQ IVL Data Shows What Pivotal Evidence Now Buys You May 19 Boston Scientific’s $1.5B MiRus Stake Marks MedTech’s Milestone Era May 18 The FDA Just Reframed Regulatory Pathway Risk for Hard-Tech Founders May 17 Physical AI Crosses From VC Bet to Incumbent Install Base May 16 Rocket Lab and RTX Confirm the Subcontractor Playbook for Defense Hardware May 15 Hard-Tech Mega-Rounds Land on the Physical Layer of the AI Stack May 14 AI Imaging and Robotic Navigation Converge in the Interventional Stack May 13 Medtronic Splits Cardiovascular Into Two Operating Stack Units as Interventional Cardiology Therapies Takes Shape May 12 IVL Platform Competition Splits Into Three Mechanisms for Calcium Modification May 11 Neptune Triton GI Robot Validates the Specialist Surgical Robotics Path May 10 SS Innovations Perth-to-India Telesurgery Reframes Surgical Robotics Platform Economics May 9 Interventional Medtech Q1 Earnings Reveal a Margin Tax Beneath the Topline May 8 AI-Embodied Surgical Robots Force a Regulatory Framework Reset May 7 BD Q2 Interventional Confirms the Surgical Consumables Layer Underneath the Robotics Build-Out May 6 J&J Ottava FORTE Pivotal Resets the Soft Tissue Surgical Robotics Stack May 5 Olympus-EndoRobotics Deal Reframes Distribution as a Surgical Robotics Channel Strategy May 4 Surgical Robotics Moves to ASCs as the Site-of-Care Shift Resets the Platform Spec May 3 Stealth AXiS Goes Global as Integrated Platforms Redraw Surgical Robotics Competition May 2 Stryker’s Q1 Cyber Recovery Reframes Resilience as a Medtech Strategic Asset May 1 CMR’s Versius Plus Gynecology Filing Anchors a Week of Indication Expansion

April 2026 10 entries Apr 30 Adagio’s VT Pivotal Anchors a Week of Specialist Interventional Wins Apr 28 CMS and FDA Launch RAPID Pathway as Medicare Coverage Compresses to Months for Breakthrough Devices Apr 27 J&J Wins CE Mark for an Ottava-Compatible Stapler Before the Robot Ships Apr 26 Boston Scientific Cuts 2026 Guidance as Watchman and EP Categories Restructure Apr 25 SS Innovations Showcases Next-Generation Surgical Robotics Platforms at SMRSC 2026 Apr 24 Intuitive Surgical Raises 2026 Outlook as Robotic Surgery Expands Into General Surgery and Gynecology Apr 23 AI-Integrated Surgical Navigation Reaches Neurosurgery as Medtronic Clears Stealth AXiS for Cranial and ENT Apr 22 Robotic Surgery Expands Into Endovascular Practice as Microbot Launches Liberty at SIR Apr 21 CMR Surgical’s US Launch and the Cost of Getting Market Entry Wrong Apr 20 The Surgical Robotics Market Is No Longer a One-Platform Decision

Every edition, in order.