Coverage

Devices

Every Devices story we’ve published, newest first — each one sourced to the primary record.

All coverage

27 stories

Devices

MHRA Flags Wear Risk in Five Modular-Neck Hip Implants

Aug 30, 20265 min read

Devices

FDA Clears Spineart’s Robotic Spine Screw App

Aug 26, 20264 min read

Manufacturing

Boston Scientific Cyberattack Halts Device Shipments

Aug 26, 20265 min read

Devices

FDA Clears Abbott’s Libre Duo Glucose-Ketone Monitor

Aug 25, 20265 min read

Devices

FDA Clears Masimo’s Root With LiDCO for Oxygen Delivery

Aug 25, 20264 min read

Devices

FDA Clears Tempus’s AI Tool for Pulmonary Hypertension

Aug 25, 20264 min read

Devices

FDA Classifies Enroute Carotid Recall as Class I

Aug 24, 20265 min read

Devices

FDA Recognizes 14 Updated Medical Device Standards

Aug 24, 20265 min read

Devices

MHRA Warns Against Infant Gas-Relief Catheters

Aug 23, 20265 min read

Devices

FDA Authorizes First Robotic Blood-Draw Device

Aug 20, 20266 min read

FDA

FDA Eases Path for Cancer Companion Diagnostics

Aug 19, 20265 min read

Devices

FDA Weighs a Competency Test for AI Medical Devices

Aug 19, 20265 min read

FDA

FDA Clears LEROCHOL Autoinjector, Adds CV Risk Claim

Aug 18, 20265 min read

Devices

FDA Sets a September Panel on GRAIL’s Galleri Blood Test

Aug 17, 20266 min read

Devices

FDA Grants Breakthrough Status to Freenome Lung Test

Aug 16, 20265 min read

Devices

TGA Suspends Supply of Corpuls Defibrillators

Aug 14, 20265 min read

Manufacturing

FDA Posts First Two Warning Letters Under New QMSR

Aug 13, 20266 min read

Devices

FDA Lets Proscia Add Scanners Without New 510(k)s

Aug 6, 20265 min read

Devices

MHRA Lifts Suspension on Belzer Organ-Preservation Fluid

Aug 6, 20264 min read

Devices

FDA Clears Sight Sciences’ OMNI Ultra for Glaucoma

Aug 4, 20265 min read

Devices

MHRA Flags Ventilator Failure Risk in Dräger Atlan Units

Aug 4, 20265 min read

Devices

FDA Clears BlueWind’s Revi Extend Bladder Implant

Aug 5, 20265 min read

Devices

FDA Classifies Ventilator, Heart-Pump Recalls as Class I

Aug 3, 20265 min read

Devices

MHRA Draws the Line on AI Scribes as Medical Devices

Jul 29, 20265 min read

Devices

FDA Gives Home COVID Tests a Permanent Class II Address

Jul 27, 20265 min read

Devices

FDA Picks Dexcom as First TEMPO Pilot Participant

Jul 24, 20266 min read

Devices

MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock

Jul 16, 20266 min read