Archive

July 2026.

Field Notes

Industry roundups

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