In the study, the device will be evaluated relative to technology that has already been FDA approved.

The recall details that the affected kits contain incorrect concentrations of Ceftriaxone antibiotic in two wells.

Are you interested in an upcoming event but unsure how to gain approval? This quick guide is for you.

The deal follows Labcorp, Quest’s rival, becoming the winning bidder to acquire Invitae’s assets.

The final rule is sure to shake up the diagnostic industry, for better or worse, depending on who you talk to.

The deal comes during a time when M&A is becoming more prevalent in the medtech industry.