June 2026.

Field Notes

Industry roundups

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