CEO Bryan Hanson told investors last week that the restructuring plan would save Solventum $120 million annually.

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.

Labcorp lists the plant as part of its consumer genetics business and plans to begin eliminating positions in May.

Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and an FDA warning letter.

This recognition underscores the FDA’s acknowledgment of Powerful Medical's STEMI AI ECG Model, dubbed “Queen of Hearts”, to ...

Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions ...

The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

Thomas Payne, HCA Healthcare’s national medical director of robotics, explains how the largest U.S. health system is vetting a new crop of market entrants.

Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.

The alert describes a problem that can lead to excessive pressure in the kidney during procedures to remove urinary stones.

The new framework is intended to make postmarket changes easier for products. Experts recommend having a clear roadmap and contacting regulators early.

Spectral AI’s system uses a physical device to capture images. The device sends multiple wavelengths of light and detects the ...