The StealthStation ENT device uses electromagnetic tracking technology to show surgeons the locations of their instruments during procedures.

Senseonics received a CE mark for its continuous glucose monitoring system with a sensor that lasts up to 180 days.

The FDA is piloting a new scheme for high-risk medical devices that removes the need for preapproval inspection.

DePuy Synthes will distribute Materialise's newly cleared 3D-printed maxillofacial implants in the U.S., starting in mid-September.

NuVasive scored FDA clearance for its spinal implant system for the treatment of early-onset scoliosis.

GE and the FDA think giving patients some control over the amount of compression applied during exams may reduce discomfort and associated stress.

Australia's Adherium scored an FDA nod for its SmartTouch device, for use with AstraZeneca’s Symbicort inhalers.

Apollo Endosurgery picked up a CE mark for its weight-loss balloon, which is designed to remain in the stomach for 12 months.

The update is intended to fix a cybersecurity weakness that allowed hackers to affect the battery life and pacing of 465,000 devices in the U.S.

Regulatory