Abbott needs to conduct more performance testing to ensure its FreeStyle Libre devices are accurate, FDA inspectors found.

The purchase will give Medtronic a larger presence in the cath lab, with a tool to help diagnose and treat coronary artery ...

The company is searching for a new leader after former CEO Stephen Farrell left when STAAR shareholders rejected a buyout ...

Amid the upheaval, Grail continued to run studies to assess the ability of its Galleri blood test to detect a range of ...

The letter, which the FDA has not yet published, does not affect Beta Bionics’ ability to market, manufacture or distribute ...

Stryker expects the robot, called Mako RPS, to bring in new customers, including more ambulatory surgery centers.

From M&A to surgical robotics and user fee negotiations, the medical device industry has a busy year ahead. Check out MedTech ...

The lawsuit questions the Trump administration’s authority to make sweeping environmental exemptions without evidence.

With Waters stockholders voting to issue shares, the companies are targeting a Feb. 9 close date for the deal.

The Center for Devices and Radiological Health said it is on track to meet review times specified by user fee agreements, ...

The company is hiring sales reps and transitioning staff from its former partner to support launches in Germany, Italy, Spain and Sweden.

Iskra will help Cleveland Diagnostics scale up commercial adoption of its IsoPSA blood-based test that analyzes the structure of protein biomarkers for prostate cancer signals.